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To investigate the application of artificial airway care under the Failure Mode and Effect Analysis (FMEA) mode in postoperative weaning patients with intracerebral hemorrhage (ICH).
A total of 137 patients who met the inclusion and exclusion criteria were selected from an affiliated hospital of Chongqing Medical University. Using a random number table, 67 patients and 70 patients were randomly assigned to the control group and the experimental group, respectively. The control group received conventional care, while the experimental group received artificial airway care based on the FMEA mode for postoperative weaning patients with cerebral hemorrhage. Data was analyzed using SPSS 27.0 to compare the incidence of pulmonary infection, re-intubation, aspiration, sputum viscosity, and tracheal tube duration between the two groups.
The incidence of pulmonary infection, re-intubation, and aspiration in the experimental group was significantly lower than that of the control group (
Artificial airway care under the FMEA mode can effectively reduce the complications in postoperative weaning patients with cerebral hemorrhage, such as pulmonary infections, re-intubation, and aspiration. It can improve PaO2 levels and sputum viscosity in arterial blood gas analysis while reduce the tracheal tube duration, and ultimately promote patient recovery.
Intracerebral hemorrhage (ICH), non-traumatic in origin, refers to spontaneous bleeding within the brain parenchyma. Most cases are caused by the rupture of blood vessels due to hypertensive small artery sclerosis. Hence, it is referred to as hypertensive intracerebral hemorrhage. It is one of the leading causes of death and disability among the population (
Previous studies (
Failure Mode and Effect Analysis (FMEA) is a proactive risk assessment and management method that systematically evaluates potential failures in a process, quantifies the risks, identifies the potential causes of failures, and formulates corrective actions to establish standardized procedures. This approach is effective in preventing or reducing the occurrence of problems (
In this study, FMEA risk management approach was used to proactively evaluate and quantify the failure points in airway management for postoperative ICH patients following weaning. The causes of these failures were analyzed to develop corrective measures. Evidence-based practices were then employed to refine nursing processes, with quality control management teams ensuring the effective implementation of these processes. This study aimed to improve the quality of clinical nursing care, ensure patient safety, and promote early recovery in patients.
A sample size analysis was conducted before the study. The sample size was calculated using the PASS 15.0 software, and the sample size calculation was chosen to compare two sample rates. At a significance level of
Patients who underwent postoperative weaning following intracerebral hemorrhage (ICH) surgery at an affiliated hospital of Chongqing Medical University between October 1, 2022, and September 30, 2024, were selected for this study. We used the random assignment for grouping. Using a computer, we generated 140 random decimal numbers in Excel. Here, the vales greater than 0.5 was assigned to the experimental group, while the values less than 0.5 was assigned to the control group. Under the hidden distribution rules, the researchers allocated the enrolled subjects to the corresponding groups based on their serial numbers. Finally, 67 patients were selected as the control group, with the remaining 70 patients assigned to the experimental group.
The control group received conventional artificial airway care interventions after weaning: (1) use of Venturi + heated humidifier oxygen therapy, with close monitoring of airway sputum viscosity; (2) suctioning performed as needed according to central negative pressure suction standards, with cuff pressure monitored every 4 h and maintained between 25 and 30 cmH2O; (3) routine oral care 3–4 times per day; and (4) routine caregiver education on turning and back-patting methods to assist with effective sputum clearance.
On top of traditional airway care interventions, the experimental group received an airway care process based on the FMEA mode for patients after weaning. A quality control management team supervised the clinical implementation of the process. This study was informed by relevant domestic and international literature (
Severity (S) scoring criteria.
| Severity level | Score | Scoring criteria |
|---|---|---|
| Extreme | 4 | Extubation failure, requiring reconnection to ventilator |
| Major/High | 3 | Extubation very likely to fail, highly likely to require reconnection to ventilator |
| Moderate | 2 | Extubation may fail, can be avoided with slight attention to prevent reconnection to ventilator |
| Minor/Low | 1 | Low possibility of extubation failure,still needs to be prevented |
Occurrence (O) scoring criteria.
| Occurrence level | Score | Scoring criteria |
|---|---|---|
| Very High/Frequent | 4 | Could happen every shift |
| High/Occasional | 3 | Could happen daily |
| Moderate/Uncommon | 2 | Could happen weekly |
| Low/Remote | 1 | Rarely happens |
Detection (D) scoring criteria.
| Detection level | Score | Scoring Criteria |
|---|---|---|
| Almost impossible | 4 | No process controls, cannot detect |
| Low | 3 | Some process controls, detection < 50% |
| Moderate | 2 | Process controls in place, detection 51–89% |
| High | 1 | Process controls in place, detection 90–100% |
According to the literature review and screening (
Catheter fixation and maintenance (3 items), selection of oxygen therapy and humidification modes (3 items), airway suction (2 items), prevention of aspiration (3 items), pulmonary rehabilitation (2 items), extubation evaluation and implementation (5 items), a questionnaire for expert consultation was created based on the team’s initial management process list. The questionnaire included expert demographics, instructions, influencing factors, and importance scoring. Using a Likert 5-point scale, experts rated the importance of each item (5 = very important, 1 = very unimportant). The experts were selected based on the following criteria: work experience ≥ 10 years; professional title: head nurse or higher, preferably at the associate senior level or above; educational background: Bachelor’s degree or higher, preferably Master’s or above; and expertise: Neurosurgery, ICU, evidence-based nursing, etc.
A total of 22 experts from 12 top-tier hospitals in Chongqing, Sichuan, and Guizhou participated in this study, including 15 associate senior or higher-level experts, 7 intermediate-level experts, 18 nursing managers, 2 respiratory therapists, and 2 senior nursing staff. After two rounds of expert consultation, two additional items were added: Assessment of sedation and analgesia (2 items), and details were adjusted according to expert feedback. The final process included 20 items. The airway care process based on the FMEA mode is summarized in
Post-operative artificial airway nursing measures for weaning patients with cerebral hemorrhage.
| Main process | Sub-process | Process details |
|---|---|---|
| Catheter fixation and maintenance | Confirm fixation | Ensure endotracheal, nasotracheal, or tracheostomy tubes are securely fixed using professional fixation devices or self-cut tape and cotton bands for dual secure fixation. |
| Dynamic assessment | Check the fixation every hour to ensure the catheter is not loose, and adjust as needed. | |
| Dressing changes | Perform sterile dressing changes at the tracheostomy site twice daily. | |
| Oxygen therapy and humidification | Oxygen therapy and humidification selection | After disconnection, the active heating and humidification system should be selected as the first choice. High-flow humidified oxygen therapy (HFNC) is the preferred option. If equipment resources are limited, a servo-type heating humidifier combined with a Venturi device can be used for oxygen therapy humidification. The temperature should be set at 31–37 °C, and the absolute humidity should be controlled to be higher than 30 mg H₂O/L. ( |
| Sputum assessment | Assess sputum consistency each shift: Grade I - thin, white, like rice soup, mildly viscous; Grade II - moderately viscous, retains small amount of sputum after suctioning; Grade III - thick, yellow, purulent, large amount of sputum retained after suctioning. | |
| Airway suctioning | Suction indications | Suction when visible sputum is present, wheezing is heard, oxygen saturation drops below 95%, or if rales are heard in both lungs. Also, suction when aspiration is suspected or if the patient cannot effectively cough up sputum. If none of these situations occur, suction once per shift for assessment and to stimulate cough reflex. |
| Procedure compliance | Follow airway suctioning procedure strictly. | |
| Prevention of aspiration | Identify high-risk patients | High-risk patients include the elderly, those with GCS < 9, head of bed < 30°, feeding rate ≥ 40 mL/h, gastric residual volume ≥ 150 mL, vomiting status, use of sedatives, muscle relaxants, or anticholinergic drugs, and those with gastrointestinal diseases. |
| Enteral nutrition care | Includes assessing enteral nutrition tolerance in high-risk patients, positioning management, post-pyloric feeding, and preventing and managing gastric retention. | |
| Cuff pressure monitoring | Correctly monitor cuff pressure every 4 h. When suctioning or changing position, recheck and adjust cuff pressure, and record findings. | |
| Restraint and sedation/pain assessment | Restraint evaluation | Evaluate using a restraint scale. Restraints are not applied if muscle strength ≤ 2 or the patient is in moderate or deep coma. If score ≥ 29, restraints are applied, reassessed every 2 h, and released for 15 min each time. Assess if restraints can be removed every 8 h or if the patient’s condition changes. |
| Sedation/pain evaluation | Perform sedation and pain assessments according to patient condition and physician orders. Use shallow sedation for easier monitoring of consciousness, muscle strength, and weaning condition. | |
| Pulmonary rehabilitation | Pulmonary physiotherapy | Develop individualized, goal-oriented pulmonary physiotherapy plans ( |
| Assisted sputum clearance | Perform nebulization 3–4 times a day, assist with turning and chest percussion every 2 h, guide in executing these techniques, and perform mechanical sputum clearance twice a day as needed | |
| Extubation evaluation and procedure | Assess the need for tube retention | Assess daily whether extubation is necessary based on stable vital signs, strong cough, and clear airway. |
| Withdrawal criteria | Withdrawal Criteria: stable vital signs, strong cough, PaO2 ≥ 60 mmHg without oxygen, PaCO2 < 50 mmHg, no airway obstruction, no recent surgery, and patient consent. Evaluate for HAP/VAP risk and if oxygenation is normal (PaO2 ≥ 60 mmHg or PaO2/FiO2 ≥ 300). | |
| Psychological care and education | Educate the patient and family on the significance of early extubation, the procedure, and the cooperation required to alleviate anxiety. | |
| Extubation procedure | Perform a leak test, deflate the cuff, and gradually remove the tube while suctioning the airway. If the leak test is unsuccessful, use medication (e.g., methylprednisolone) and extubate after 10 min. | |
| Post-extubation monitoring | Monitor for complications such as sore throat, swallowing difficulty, or oxygen saturation drops. If oxygen saturation decreases, administer high-flow oxygen therapy (HFNC) and be prepared for reintubation. |
Firstly, a quality control management team was established, consisting of research members from the project team. The team would implement a three-level nursing management system: head nurse - nursing group leader - responsible nurse. The team consists of 7 members, including 2 head nurses, 4 nursing group leaders, and 1 assistant head nurse. Team members would analyze the issues in airway management of patients after weaning. Define clear nursing objectives and ensure effective implementation. The nursing group leader would complete the “Postoperative Airway Management Daily Inspection Form for Hemorrhagic Stroke Patients After Weaning,” ensuring the effective implementation of nursing procedures during weaning, thus improving the quality of patient care. Evaluate the results of the objectives. During the implementation phase, regular team meetings were performed to continuously evaluate and adjust the plan to achieve the expected objectives.
The airway sputum viscosity between the two groups of patients was compared. The criteria for assessment are shown in
The blood gas analysis indicators between the two groups of patients were compared: Blood gas analysis would be performed on PaO2 and PaCO2 values once within 24 h after weaning and once before extubation.
The incidence of pulmonary infections between the two groups of patients was compared. Diagnostic criteria for pulmonary infection: Chest X-ray shows pulmonary infiltration shadows or new inflammatory lesions; signs of pulmonary consolidation and/or the presence of wet sounds during lung auscultation, with one of the following conditions: (1) Peripheral blood white blood cell count >10×10^9/L or <4×10^9/L, with or without nuclear shift; (2) Fever, body temperature >37.5 °C, and large amounts of purulent respiratory secretions; and (3) New pathogens isolated from bronchial secretions. Ventilator-Associated Pneumonia (VAP) needs to be excluded, which refers to pneumonia that occurs 48 h after mechanical ventilation or within 48 h after extubation. This determination was performed through a combined assessment of the temporal window and clinical context.
The reintubation rates between the two groups were compared, specifically the reintubation rate within 24 h after weaning.
The duration of the endotracheal tube in place between the two groups was compared, specifically the time from successful weaning to the removal of the endotracheal tube.
Statistical analysis was conducted using SPSS 27.0 software. Count data is expressed as frequency and percentage. Group comparisons were performed using the chi-square test. Measurement data is expressed as mean ± standard deviation (c ± s). The corresponding group comparisons were conducted using the t-test. A
We used the random assignment for grouping. A total of 137 patients were included. Sixty-seven patients (46 males and 21 females with an average age of 58.40 ± 12.14 years) were randomly selected as the control group. Seventy patients were assigned to the experimental group, consisting of 44 male and 26 female patients with an average age of 56.34 ± 11.99 years. There were no statistically significant differences between the two groups in terms of age, sex, hemorrhagic stroke location or bleeding volume (
General information of patients.
| Item | Control group ( |
Experimental group ( |
Statistic | |
|---|---|---|---|---|
| Sex | 0.291 | |||
| Male | 46 | 42 | ||
| Female | 21 | 28 | ||
| Age | 58.40 ± 12.14 | 56.34 ± 12.00 | 0.320 | |
| bleeding volume | 28.99 ± 10.12 | 26.81 ± 8.93 | 0.185 | |
| Bleeding site | FET = 1.277 | 0.960 | ||
| Basal ganglia | 30 | 29 | ||
| Brainstem | 2 | 3 | ||
| Ventriculus cerebri | 9 | 12 | ||
| Lobe | 17 | 19 | ||
| Thalamus | 3 | 3 | ||
| Cerebellum | 6 | 4 |
X2 = chi-square test;
The experimental group adopted the artificial airway process based on the FMEA model. The rates of pulmonary infection, re-mechanical ventilation, and aspiration were all lower than those in the control group (
Comparison of complication rates.
| Group | Sample size | Pulmonary infection rate | Secondary mechanical ventilation rate | Aspiration rate |
|---|---|---|---|---|
| Control group | 67 | 12 (17.91%) | 8 (11.94%) | 7 (10.44%) |
| Experimental group | 70 | 2 (2.85%) | 2 (2.85%) | 1 (1.43%) |
| 8.455 | 4.174 | 5.065 | ||
| 0.003 | 0.041 | 0.027 |
Before the intervention, there was no significant difference in sputum viscosity between the two groups. However, a significant difference was observed after the intervention (
Comparison of phlegm viscosity.
| Group | Sputum characteristics before intervention | Sputum characteristics after intervention | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Absence | I degree | II degree | III degree | Absence | I degree | II degree | III degree | |||
| Control group ( |
0 | 9 | 38 | 20 | 2 | 18 | 39 | 8 | 9.460 | 0.02 |
| Experimental group ( |
2 | 14 | 38 | 16 | 15 | 33 | 22 | 0 | 38.928 | <0.001 |
| 2.153 | 26.050 | |||||||||
| 0.142 | <0.001 | |||||||||
H, Kruskal-Wallis H;
Before the intervention, there was no statistically significant difference in PaO2 and PaCO2 between the two groups (
Comparison of blood gas index PaO2 AND PACO2.
| Item | Control group ( |
Experimental group ( |
|||
|---|---|---|---|---|---|
| PACO2 | Pre-intervention | 37.64 ± 4.19 | 37.09 ± 3.92 | 1.054 | 0.294※ |
| Post-intervention | 37.19 ± 4.32 | 35.84 ± 4.17 | 1.797 | 0.075※ | |
| PAO2 | Pre-intervention | 142.92 ± 54.34 | 130.17 ± 44.24 | – | 0.348‡ |
| Post-intervention | 95.24 ± 19.22 | 104.43 ± 19.78 | 2.701 | 0.008※ | |
※ Unpaired
The comparison of endotracheal tube duration between the two groups revealed a statistically significant difference. The experimental group had a significantly shorter duration of tracheal catheter placement after weaning compared to the control group (p<0.001), indicating a highly significant reduction in tube duration in the experimental group, as shown in
Comparison of the time to carry tracheal catheter.
| Group | Sample size | Time to carry the tracheal catheter |
|---|---|---|
| Control group | 67 | 7.73 ± 10.13 |
| Experimental group | 70 | 3.91 ± 5.02 |
| 2.817 | ||
| <0.001 |
Patients after hemorrhagic stroke often experience prolonged endotracheal intubation due to some factors such as suppression of the respiratory center, neurogenic brain edema, or consciousness impairment. Although weaning from the ventilator may be attempted once weaning criteria are met, artificial airway management following ventilator weaning remains a critical component prior to extubation. Existing studies (
This study innovatively introduced FMEA, a proactive risk management tool, to systematically optimize the artificial airway care process for postoperative weaning patients with cerebral hemorrhage. Using FMEA, we identified and quantified potential failure modes in the nursing process, implemented corrective measures, and established standardized protocols. The results demonstrated that the FMEA-based nursing protocol significantly reduced the incidence of pulmonary infection, reintubation, and aspiration. This improvement can be attributed to the refined management of key aspects such as airway humidification, oxygen therapy mode selection, aspiration prevention, and pulmonary rehabilitation, ensuring consistency and quality in care delivery. Studies by Li et al. (
This study focused on a high-risk yet often overlooked population—postoperative weaning patients with cerebral hemorrhage—providing both empirical evidence and a practical workflow for airway management. As a systematic and proactive methodology, FMEA has demonstrated value across various nursing contexts. Studies by Chen et al. (
This study has several limitations. First, the data were derived from a single center in Chongqing, which may limit generalizability. Future multi-center studies with larger samples are needed to validate the effectiveness and scalability of the proposed protocol. Second, although this study focuses on key failure modes, further optimization of ancillary processes can enhance overall airway care quality.
In conclusion, by introducing the FMEA model, this study developed a scientific, systematic, and operable artificial airway care protocol for postoperative weaning patients with cerebral hemorrhage. Implemented through a three-tier quality control system, this protocol significantly improved nursing quality, reduced complication rates, enhanced blood gas parameters and sputum viscosity, shortened endotracheal intubation duration, and ultimately promoted patient recovery.
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
The studies involving humans were approved by The study was conducted in accordance with the Declaration of Helsinki and ethical approval was obtained from the Second Affiliated Hospital of Chongqing Medical University, Project ID: No. 2024-EC-73. The studies were conducted in accordance with the local legislation and institutional requirements. Written informed consent for participation in this study was provided by the participants’ legal guardians/next of kin.
XT: Conceptualization, Data curation, Methodology, Project administration, Investigation, Writing – original draft. JY: Data curation, Investigation, Writing – original draft. YC: Investigation, Writing – original draft, Methodology. RZ: Writing – original draft, Software, Validation. CW: Software, Writing – original draft, Conceptualization, Investigation. TZ: Investigation, Writing – original draft, Data curation. XG: Data curation, Conceptualization, Methodology, Project administration, Writing – review & editing.
The author(s) declare that no financial support was received for the research and/or publication of this article.
We express our gratitude to the consultant expert for their valuable comments and suggestions of an earlier version of nursing procedure. We are also grateful to the reviewers for the insightful comments and suggestions that have helped us improve the study’s quality.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
The authors declare that no Gen AI was used in the creation of this manuscript.
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