NCT07287293

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

November 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

November 15, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

Airway ManagementSuctioningEmergence from AnesthesiaHypoxiaEndotracheal IntubationPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Incidence and severity of postoperative coughing

    First 60 minutes after extubation

  • Severity of sore throat during swallowing

    First 60 minutes after extubation

  • Requirement and level of oxygen therapy

    First 60 minutes after extubation

  • Incidence of postoperative nausea and vomiting

    First 60 minutes after extubation

  • Patient satisfaction

    At 24 hours after surgery (± 2 hours)

  • +1 more secondary outcomes

Other Outcomes (1)

  • Duration of stay in the post-anesthesia care unit (PACU)

    From arrival in the PACU until discharge from the PACU, assessed up to 6 hours after PACU arrival.

Study Arms (2)

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.

Procedure: Routine Endotracheal Suctioning

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.

Procedure: Omission of Endotracheal Suctioning

Interventions

Endotracheal suctioning performed immediately prior to extubation using standard suction pressure and technique. Oropharyngeal suctioning was also performed according to routine clinical practice.

Also known as: SUC
Routine Endotracheal Suctioning (SUC)

Oropharyngeal suctioning only was performed prior to extubation. No suction catheter was inserted into the trachea.

Also known as: NON-SUC
Omission of Endotracheal Suctioning (NON-SUC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Somdetphraphutthaloetla hospital

Samut Sakhon, 75000, Thailand

RECRUITING

Related Publications (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

HypoxiaAirway ObstructionPharyngitisCoughPostoperative Complications

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesPathologic Processes

Central Study Contacts

Saowaluk Sotananan, Doctor of Medicine

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2025

First Posted

December 17, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations