- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287293
Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia
Comparison of Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia With Endotracheal Intubation: A Randomized, Single-Blind Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Saowaluk Sotananan, Doctor of Medicine
- Phone Number: +66894549111
- Email: pum.sotananan@gmail.com
Study Locations
-
-
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Samut Sakhon, Thailand, 75000
- Recruiting
- Somdetphraphutthaloetla hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Routine Endotracheal Suctioning (SUC)
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.
|
Endotracheal suctioning performed immediately prior to extubation using standard suction pressure and technique.
Oropharyngeal suctioning was also performed according to routine clinical practice.
Other Names:
|
|
Experimental: Omission of Endotracheal Suctioning (NON-SUC)
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.
|
Oropharyngeal suctioning only was performed prior to extubation.
No suction catheter was inserted into the trachea.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative desaturation after extubation
Time Frame: First 60 minutes 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and severity of postoperative coughing
Time Frame: First 60 minutes after extubation
|
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
|
|
Severity of sore throat during swallowing
Time Frame: First 60 minutes after extubation
|
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
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|
Requirement and level of oxygen therapy
Time Frame: First 60 minutes after extubation
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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
|
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Incidence of postoperative nausea and vomiting
Time Frame: First 60 minutes after extubation
|
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
Time Frame: At 24 hours after surgery (± 2 hours)
|
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.
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At 24 hours after surgery (± 2 hours)
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Incidence of extubation-related adverse events
Time Frame: From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival.
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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.
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From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of stay in the post-anesthesia care unit (PACU)
Time Frame: From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival.
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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.
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From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Pathologic Processes
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Otorhinolaryngologic Diseases
- Signs and Symptoms, Respiratory
- Pharyngeal Diseases
- Respiratory Insufficiency
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hypoxia
- Cough
- Airway Obstruction
- Postoperative Complications
- Pharyngitis
Other Study ID Numbers
- Suction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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