Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT07287293
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Comparison of Endotracheal Tube Suctioning Versus No Suctioning During Emergence From General Anesthesia With Endotracheal Intubation: A Randomized, Single-Blind Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: