Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia

Официальное название

Comparison of Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia With Endotracheal Intubation: A Randomized, Single-Blind Study

Обзор

The goal of this study is to determine whether omitting tracheal suctioning immediately prior to extubation is non-inferior to routine tracheal suctioning with respect to early postoperative oxygenation among adult surgical patients (aged 18-90 years, American Society of Anesthesiologists \[ASA\] physical status I-III) undergoing elective surgery under general anesthesia with endotracheal intubation. The study addresses the following questions: * Primary outcome (non-inferiority): * Is the risk of postoperative desaturation (oxygen saturation \[SpO₂\] \<92% within 60 minutes after extubation) in the no-suction group not worse than in the routine-suction group by more than 10 percentage points? * Secondary outcomes (superiority): * Does omitting tracheal suctioning reduce postoperative cough severity and sore throat? * Does omitting tracheal suctioning avoid increasing extubation-related adverse events? Participants will be randomly assigned (1:1) to one of two groups: * Routine suctioning (SUC): Endotracheal suctioning plus oropharyngeal suctioning immediately before extubation * No suctioning (NON-SUC): Oropharyngeal suctioning only, without endotracheal suctioning All participants will receive standard anesthetic care and postoperative monitoring in the post-anesthesia care unit (PACU) for 60 minutes. Follow-up for airway symptoms and patient satisfaction will be conducted at 24 hours after surgery.

Вмешательства

• Процедура Routine Endotracheal Suctioning
  Endotracheal suctioning performed immediately prior to extubation using standard suction pressure and technique. Oropharyngeal suctioning was also performed according to routine clinical practice.
• Процедура Omission of Endotracheal Suctioning
  Oropharyngeal suctioning only was performed prior to extubation. No suction catheter was inserted into the trachea.

Первичные конечные точки

• Incidence of postoperative desaturation after extubation [Срок оценки: First 60 minutes after extubation]

Вторичные конечные точки (6)

• Incidence and severity of postoperative coughing [Срок оценки: First 60 minutes after extubation]
• Severity of sore throat during swallowing [Срок оценки: First 60 minutes after extubation]
• Requirement and level of oxygen therapy [Срок оценки: First 60 minutes after extubation]
• Incidence of postoperative nausea and vomiting [Срок оценки: First 60 minutes after extubation]
• Patient satisfaction [Срок оценки: At 24 hours after surgery (± 2 hours)]
• Incidence of extubation-related adverse events [Срок оценки: From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival.]

Критерии участия

Критерии включения

• Adults aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III.
• Scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
• Planned tracheal extubation in the operating room at the end of surgery.

Критерии исключения

• Inability to provide informed consent or the presence of a significant language barrier that prevents effective communication with the clinical team.
• Known diagnosis of obstructive sleep apnea (OSA), active pneumonia, or chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, restrictive lung disease).
• Body mass index (BMI) >35 kg/m².
• Pregnancy or increased aspiration risk (e.g., full stomach).
• Scheduled for maxillofacial, head and neck, or airway surgery.
• Anticipated surgical duration >3.5 hours.
• Anticipated difficult airway, defined as the presence of ≥2 predictors of difficult mask ventilation (DMV) based on Langeron et al., or a documented history of difficult intubation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Таиланд · 1 центр

• Somdetphraphutthaloetla hospital — Samut Sakhon

Публикации

• Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3. PMID 31587835
• Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1. PMID 7160191
• Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009. PMID 10781266
• Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990 Dec;9(12):1447-54. doi: 10.1002/sim.4780091208. PMID 2281232
• Tung A, Fergusson NA, Ng N, Hu V, Dormuth C, Griesdale DGE. Pharmacological methods for reducing coughing on emergence from elective surgery after general anesthesia with endotracheal intubation: protocol for a systematic review of common medications and network meta-analysis. Syst Rev. 2019 Jan 24;8(1):32. doi: 10.1186/s13643-019-0947-2. PMID 30678727
• Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52. PMID 15385385
• L'Hermite J, Wira O, Castelli C, de La Coussaye JE, Ripart J, Cuvillon P. Tracheal extubation with suction vs. positive pressure during emergence from general anaesthesia in adults: A randomised controlled trial. Anaesth Crit Care Pain Med. 2018 Apr;37(2):147-153. doi: 10.1016/j.accpm.2017.07.005. Epub 2017 Sep 4. PMID 28882741
• Radkowski P, Oniszczuk H, Opolska J, Pawluczuk M, Samiec M, Mieszkowski M. A Review of Non-Cardiac Complications of General Anesthesia: The Current State of Knowledge. Med Sci Monit. 2025 Apr 17;31:e947561. doi: 10.12659/MSM.947561. PMID 40241288

Идентификаторы

NCT: NCT07287293 · Suction

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗