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Endotracheal Tube Intolerance and Respiratory Airflow Perception

2026년 8월 11일 업데이트: Yi Feng, MD, Peking University People's Hospital

Association Between Preoperative Oronasal Breathing Patterns and Endotracheal Tube Intolerance During Emergence From General Anesthesia: A Prospective Nested Case-Control Study

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.

연구 개요

상태

아직 모집하지 않음

상세 설명

Eligible patients will be enrolled for observation. Based on whether coughing occurs before extubation after emergence from anesthesia, patients will be divided into a case group (those who develop coughing) and a control group (those who do not).

Non-invasive cuff blood pressure readings will be recorded before, during, and after extubation. Post-extubation pain scores and sedation levels (assessed using the Ramsay Sedation Scale) will also be documented.

General demographic characteristics, smoking and smoking cessation history, presence of snoring during sleep, comorbid conditions (with particular emphasis on sleep apnea-hypopnea syndrome), history of pulmonary diseases, mode of spontaneous breathing, and surgical and anesthetic data will be collected.

Primary outcome: occurrence of coughing before extubation after emergence from anesthesia.

Definition of coughing: Coughing is defined as the occurrence of cough in a patient who has emerged from anesthesia after administration of reversal agents at the end of surgery, while the tracheal tube is still in place and connected to the ventilator in manual ventilation mode (with the adjustable pressure limiting [APL] valve set at 0 cmH₂O), and when extubation criteria have been met but the tube has not yet been removed.

Severity of coughing is graded as follows:

0 = no cough;

  1. = single cough;
  2. = more than one non-sustained cough;
  3. = sustained and repetitive cough with head lifting.

Data collection methods: General demographic and surgical/anesthetic data will be retrieved retrospectively from the patients' medical and anesthesia records. Other relevant data, including the occurrence and severity of coughing, pain scores, sedation levels, and mode of spontaneous breathing, will be recorded directly by the investigators in the case report forms (CRFs).

Investigators: research staff who have undergone standardized training.

This is an exploratory, unmatched case-control study designed to investigate the association between coughing during emergence from general anesthesia and the mode of spontaneous breathing (nasal vs. oral) in patients. In the pilot study, the proportion of nasal breathing in the case group (cough) was 65%, while that in the control group (no cough) was 35%. With a two-sided significance level (α = 0.05) and a statistical power of 90%, the required sample size per group was calculated using the Schlesselman formula to be 89 patients. Accounting for a 20% dropout rate, a total of 224 patients (112 per group) are planned for final enrollment. If the observed difference in exposure proportions is smaller than anticipated, the recruitment period will be extended or the analytical strategy will be adjusted accordingly.

연구 유형

관찰

등록 (추정된)

224

연락처 및 위치

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연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

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예

샘플링 방법

확률 샘플

연구 인구

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.

설명

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Mouth Breathing
The patients' breathing pattern is predominantly oral.
Nasal Breathing
The patients' breathing pattern is predominantly nasal.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Endotracheal Tube Intolerance
기간: Pre-extubation period

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

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2026년 10월 31일

연구 완료 (추정된)

2026년 10월 31일

연구 등록 날짜

최초 제출

2026년 7월 22일

QC 기준을 충족하는 최초 제출

2026년 8월 11일

처음 게시됨 (실제)

2026년 8월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 11일

마지막으로 확인됨

2026년 7월 1일

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