Endotracheal Tube Intolerance and Respiratory Airflow Perception

NCT07759284 | Not Yet Recruiting

• 1 other identifier: 2025-z173
• Study Type: observational
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a case-control study designed to enroll 224 patients who will undergo tracheal intubation for general anesthesia in the operating rooms of Peking University People's Hospital between July 20, 2026, and October 31, 2026. The case group will consist of patients who develop coughing before extubation (N=112), while the control group will comprise those without coughing before extubation (N=112). Data to be collected include general demographic characteristics, smoking and smoking cessation history, comorbid conditions (with particular attention to snoring during sleep and sleep apnea-hypopnea syndrome \[SAHS\]), history of pulmonary diseases, mode of spontaneous breathing, surgical and anesthetic data, as well as blood pressure and heart rate before, during, and after extubation, pain scores, and sedation levels. Continuous variables will be presented as mean ± standard deviation (for normally distributed data) or median with interquartile range (IQR) (for non-normally distributed data). Categorical variables will be described using frequencies and percentages (e.g., sex, smoking history). Baseline differences between the case and control groups will be compared using the chi-square test (for categorical variables), Student's t-test (for normally distributed continuous variables), or the Mann-Whitney U test (for non-normally distributed continuous variables). Multivariable logistic regression analysis will be employed to evaluate the independent association between the mode of spontaneous breathing and coughing before extubation, with adjustment for potential confounding factors, and odds ratios (ORs) with their 95% confidence intervals (95%CI) will be calculated. All statistical analyses will be performed using SPSS or R software.

Conditions

Coughing Responses at Tracheal Extubation; Breathing Patterns

Keywords

Oronasal Breathing Pattern; Endotracheal Tube Intolerance; Emergence from General Anaesthesia; Nested Case-Control Study

Outcome Measures

Primary Outcomes (1)

• Endotracheal Tube Intolerance

  Definition of Bucking / Emergence Coughing: Bucking is defined as a reflexive cough occurring during the emergence phase following the administration of reversal agents at the conclusion of surgery. It manifests while the patient is mechanically ventilated in the manual ventilation mode via the endotracheal tube (with the adjustable pressure-limiting \[APL\] valve set at 0 cmH₂O), after extubation criteria have been met but prior to the actual removal of the tracheal tube. Severity Grading of Bucking (Clinical Scale): Grade 0: No bucking. Grade 1: Isolated, single cough. Grade 2: Intermittent coughing (more than one episode, non-sustained). Grade 3: Sustained, repetitive coughing accompanied by head lifting (indicating severe emergence agitation/reflex).

  Pre-extubation period

Study Arms (2)

Mouth Breathing

The patients' breathing pattern is predominantly oral.

Nasal Breathing

The patients' breathing pattern is predominantly nasal.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 224 patients undergoing general anesthesia with endotracheal intubation in the operating rooms of Peking University People's Hospital will be recruited between July 20, 2026, and October 31, 2026.

You may qualify if:

• Patients undergoing general anesthesia with endotracheal intubation;
• Written informed consent obtained.

You may not qualify if:

• Patients with severe psychiatric disorders;
• Deaf or mute patients who are unable to answer questions;
• Patients who develop postoperative cognitive dysfunction and are consequently unable to answer questions;
• Patients who withdraw from the study prematurely;
• Patients who are extubated after being transferred to the recovery room or intensive care unit (i.e., extubation not performed in the operating room).

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (21)

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Central Study Contacts

Xiaoyan Li

CONTACT

010-88325581; lixiaoyan_j@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Anesthesiology

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share