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Coughing Responses at Tracheal ExtubationNCT07759284

Endotracheal Tube Intolerance and Respiratory Airflow Perception

An observational study of Coughing Responses at Tracheal Extubation and Breathing Patterns, run by Peking University People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Type of treatment
Pill or oral medicine
How many people
224 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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.

Read the detailed description

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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07759284
Study groupRoleWhat they receive
Mouth BreathingThe patients' breathing pattern is predominantly oral.
Nasal BreathingThe patients' breathing pattern is predominantly nasal.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Pre-extubation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07759284
Sponsor's protocol ID
2025-z173
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The confidentiality of all patient information will be strictly maintained.

Publications

  • Cui XL, Ma MJ, Wang L, Yu XR, Huang YG. Influence of Sex on Remifentanil's Cough-prevention Effect during Anesthetic Emergence. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2015 Jun;37(3):335-8. doi: 10.3881/j.issn.1000-503X.2015.03.017.

    PubMed 26149148
  • Salim B, Rashid S, Ali MA, Raza A, Khan FA. Effect of Pharmacological Agents Administered for Attenuating the Extubation Response on the Quality of Extubation: A Systematic Review. Cureus. 2019 Dec 20;11(12):e6427. doi: 10.7759/cureus.6427.

    PubMed 31993265
  • Chang CH, Lee JW, Choi JR, Shim YH. Effect-site concentration of remifentanil to prevent cough after laryngomicrosurgery. Laryngoscope. 2013 Dec;123(12):3105-9. doi: 10.1002/lary.24199. Epub 2013 May 31.

    PubMed 23686891
  • Lee SY, Yoo JY, Kim JY, Kim DH, Lee JD, Rho GU, Park H, Park SY. Optimal effect-site concentration of remifentanil for preventing cough during removal of the double-lumen endotracheal tube from sevoflurane-remifentanil anesthesia: A prospective clinical trial. Medicine (Baltimore). 2016 Jun;95(24):e3878. doi: 10.1097/MD.0000000000003878.

    PubMed 27310976
  • Fan X, Cai H, Pan B, Xie Y. Comparison of dexmedetomidine and remifentanil on reducing coughing during emergence from anesthesia with tracheal intubation: A meta-analysis. Front Pharmacol. 2022 Sep 30;13:993239. doi: 10.3389/fphar.2022.993239. eCollection 2022.

    PubMed 36249748
  • Sakae TM, Souza RLP, Brand Uo JCM. Impact of topical airway anesthesia on immediate postoperative cough/bucking: a systematic review and meta-analysis. Braz J Anesthesiol. 2023 Jan-Feb;73(1):91-100. doi: 10.1016/j.bjane.2021.03.016. Epub 2021 Apr 22.

    PubMed 33895219
  • Lv L, Yan L, Liu X, Chen M. Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study. BMC Geriatr. 2020 May 4;20(1):157. doi: 10.1186/s12877-020-01567-y.

    PubMed 32366224
  • Viguera M, Diakum TA, Shelsky R, Casals P, Cochs J, Fauli A. [Efficacy of topical administration of lidocaine through a Malinckrodt Hi-Lo Jet tube in lessening cough during recovery from general anesthesia]. Rev Esp Anestesiol Reanim. 1992 Sep-Oct;39(5):316-8. Spanish.

    PubMed 1410755
  • Hartley M, Vaughan RS. Problems associated with tracheal extubation. Br J Anaesth. 1993 Oct;71(4):561-8. doi: 10.1093/bja/71.4.561. No abstract available.

    PubMed 8260307
  • Lee JS, Choi SH, Kang YR, Kim Y, Shim YH. Efficacy of a single dose of dexmedetomidine for cough suppression during anesthetic emergence: a randomized controlled trial. Can J Anaesth. 2015 Apr;62(4):392-8. doi: 10.1007/s12630-014-0295-6. Epub 2014 Dec 19.

    PubMed 25523837
  • Miller KA, Harkin CP, Bailey PL. Postoperative tracheal extubation. Anesth Analg. 1995 Jan;80(1):149-72. doi: 10.1097/00000539-199501000-00025. No abstract available.

    PubMed 7802273
  • Dyson A, Isaac PA, Pennant JH, Giesecke AH, Lipton JM. Esmolol attenuates cardiovascular responses to extubation. Anesth Analg. 1990 Dec;71(6):675-8. doi: 10.1213/00000539-199012000-00017.

    PubMed 1978612
  • Fang P, Zong Z, Lu Y, Han X, Liu X. Effect of topical ropivacaine on the response to endotracheal tube during emergence from general anesthesia: a prospective randomized double-blind controlled study. BMC Anesthesiol. 2018 Sep 27;18(1):134. doi: 10.1186/s12871-018-0601-x.

    PubMed 30261837
  • Takahata O, Iwasaki H. [Problems and complications in airway management by endotracheal intubation and laryngeal mask airway]. Masui. 2006 Jan;55(1):44-50. Japanese.

    PubMed 16440706
  • Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

    PubMed 26556848

Questions about this trial

What is this clinical trial studying?

An observational study of Coughing Responses at Tracheal Extubation and Breathing Patterns, run by Peking University People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoyan Li (010-88325581, lixiaoyan_j@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endotracheal Tube Intolerance (time frame: Pre-extubation period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07759284, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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