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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:
Participants will be randomly assigned (1:1) to one of two groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Endotracheal Suctioning (SUC) | Active Comparator | Participants in this arm received routine endotracheal suctioning immediately prior to extubation, performed using standard suction pressure and technique. Oropharyngeal suctioning was also performed according to usual clinical practice. |
|
| Omission of Endotracheal Suctioning (NON-SUC) | Experimental | Participants in this arm received oropharyngeal suctioning only prior to extubation. No suction catheter was inserted into the trachea. Standard anesthetic care and monitoring were provided as per routine practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Endotracheal Suctioning | Procedure | Endotracheal suctioning performed immediately prior to extubation using standard suction pressure and technique. Oropharyngeal suctioning was also performed according to routine clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative desaturation after extubation | Proportion of participants who develop desaturation, defined as peripheral oxygen saturation (SpO₂) <92% at any time within the first 60 minutes after extubation. | First 60 minutes after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of postoperative coughing | Incidence and severity of postoperative coughing within the first 60 minutes after extubation, assessed using the modified Minogue scale. Severity is recorded as the highest coughing score observed during the assessment period. | First 60 minutes after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of stay in the post-anesthesia care unit (PACU) | Total duration of stay in the post-anesthesia care unit (PACU), recorded in minutes from arrival in PACU until discharge based on standard discharge criteria. The PACU stay typically lasts 2-3 hours depending on discharge criteria. | From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saowaluk Sotananan, Doctor of Medicine | Contact | +66894549111 | pum.sotananan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Somdetphraphutthaloetla hospital | Recruiting | Samut Sakhon | 75000 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31587835 | Result | 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. | |
| 7160191 |
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Individual participant data will not be shared because the ethics committee approval and institutional data governance policies do not allow external sharing of identifiable or de-identified participant-level data. Access to study data is restricted to the research team to protect participant confidentiality and comply with local regulatory requirements.
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D000402 | Airway Obstruction |
| D010612 | Pharyngitis |
| D003371 | Cough |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012131 | Respiratory Insufficiency |
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Interventions
Routine Suctioning Group (SUC):
Participants received both endotracheal suctioning and oropharyngeal suctioning immediately prior to extubation, performed using standard suction pressure and technique.
No Suctioning Group (NON-SUC):
Participants received oropharyngeal suctioning only. No suction catheter was inserted into the trachea prior to extubation.
If the anesthesiologist identified copious airway secretions requiring clearance for patient safety, endotracheal suctioning was performed. These participants were subsequently excluded from the analysis as per the predefined protocol.
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The anesthesiologist performing the intervention, the participants, and the investigators involved in intraoperative care and data collection were not masked because the suctioning procedures could not be concealed. The outcomes assessor, responsible for recording postoperative oxygen saturation, airway symptoms, and patient-reported outcomes, was blinded to the group assignment.
|
| Omission of Endotracheal Suctioning | Procedure | Oropharyngeal suctioning only was performed prior to extubation. No suction catheter was inserted into the trachea. |
|
|
| Severity of sore throat during swallowing |
Severity of sore throat during swallowing within the first 60 minutes after extubation, assessed using a 0-10 numerical rating scale (NRS). The outcome is recorded as the highest score reported during the assessment period. |
| First 60 minutes after extubation |
| Requirement and level of oxygen therapy | Requirement for oxygen therapy and the highest level of escalation within the first 60 minutes after extubation, including nasal cannula, simple face mask, reservoir mask, or more advanced oxygen delivery devices as clinically indicated. | First 60 minutes after extubation |
| Incidence of postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting occurring within the first 60 minutes after extubation. Nausea and vomiting are recorded as present or absent during the assessment period. | First 60 minutes after extubation |
| Patient satisfaction | Patient satisfaction with anesthetic care at 24 hours after surgery, assessed using a 0-10 numerical rating scale (NRS), where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. The recorded value represents the patient's reported score at the 24-hour assessment. | At 24 hours after surgery (± 2 hours) |
| Incidence of extubation-related adverse events | Incidence of extubation-related adverse events during the post-anesthesia care unit (PACU) stay, including bronchospasm, laryngospasm, reintubation, and post-obstructive pulmonary edema. Events are recorded as present or absent throughout the PACU monitoring period. The PACU stay typically lasts 2-3 hours depending on discharge criteria. | From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival. |
| Result |
| 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. |
| 10781266 | Result | 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. |
| 2281232 | Result | 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. |
| 30678727 | Result | 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. |
| 15385385 | Result | 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. |
| 28882741 | Result | 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. |
| 40241288 | Result | 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. |
| 8260307 | Result | 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. |
| 22321104 | Result | Difficult Airway Society Extubation Guidelines Group; Popat M, Mitchell V, Dravid R, Patel A, Swampillai C, Higgs A. Difficult Airway Society Guidelines for the management of tracheal extubation. Anaesthesia. 2012 Mar;67(3):318-40. doi: 10.1111/j.1365-2044.2012.07075.x. |
| 34840816 | Result | Benham-Hermetz J, Mitchell V. Safe tracheal extubation after general anaesthesia. BJA Educ. 2021 Dec;21(12):446-454. doi: 10.1016/j.bjae.2021.07.003. Epub 2021 Aug 25. No abstract available. |
| 21447488 | Result | Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29. |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |