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- Ensaio Clínico NCT07759284
Endotracheal Tube Intolerance and Respiratory Airflow Perception
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.
Visão geral do estudo
Status
Descrição detalhada
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;
- = single cough;
- = more than one non-sustained cough;
- = 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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Xiaoyan Li
- Número de telefone: 010-88325581
- E-mail: lixiaoyan_j@163.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Mouth Breathing
The patients' breathing pattern is predominantly oral.
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Nasal Breathing
The patients' breathing pattern is predominantly nasal.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Endotracheal Tube Intolerance
Prazo: Pre-extubation period
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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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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.
- 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.
- Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Ni Eochagain A, Athanassoglou V, Cumberworth A, Morris O, Corbett S, Jefferson H, O'Sullivan EP, Pandit JJ. Assessing a novel second generation laryngeal mask airway using the 'ADEPT' approach: results from the LMA(R) Protector observational study. J Clin Monit Comput. 2023 Apr;37(2):517-524. doi: 10.1007/s10877-022-00910-5. Epub 2022 Sep 5.
- Kleine-Brueggeney M, Gottfried A, Nabecker S, Greif R, Book M, Theiler L. Pediatric supraglottic airway devices in clinical practice: A prospective observational study. BMC Anesthesiol. 2017 Sep 2;17(1):119. doi: 10.1186/s12871-017-0403-6.
- Sharma B, Sahai C, Sood J. Extraglottic airway devices: technology update. Med Devices (Auckl). 2017 Aug 17;10:189-205. doi: 10.2147/MDER.S110186. eCollection 2017.
- Durbin CG Jr, Bell CT, Shilling AM. Elective intubation. Respir Care. 2014 Jun;59(6):825-46; discussion 847-9. doi: 10.4187/respcare.02802.
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