Supraglottic Airway vs Tracheal Intubation on PPCs Among High-risk Geriatric Patients

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Complication
• Interventions: Device: laryngeal mask airway and endotracheal tube

• Registration Number: NCT06391333
• Lead Sponsor: RenJi Hospital

Brief Summary

Postoperative pulmonary complications are serious threat to surgical patients, especially to high-risk geriatric patients. There is evidence that laryngeal mask airway is associated with postoperative pulmonary complications in comparison with tracheal intubation. However, conclusion may reverse among frail population such as high-risk geriatric patients. Geriatric patients are often associated with loose mask seal due to physiological changes, which may increase chances of aspiration and pose challenges to intraoperative airway maintenance. It was reported that laryngeal mask airway causes more atelectasis among children, but no report among high-risk elderly. The investigators therefore propose this study to verify the non-inferior effect of laryngeal mask airway compared to tracheal intubation on postoperative pulmonary complications among high-risk geriatric patients undergoing elective non-cardiothoracic surgeries.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Study Start: 2024-05-05
• Primary Completion: 2026-04-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2210

Inclusion Criteria

• Patients aged ≥ 70 years scheduled for elective non-cardiothoracic surgery with an ARISCAT score > 44 will be included

Exclusion Criteria

• Exclusion criteria include emergency surgery; anticipated difficult tracheal intubation; laryngeal pathology that might interfere with supraglottic device insertion; high risk of gastroesophageal reflux; participation in any conflicting trial within the past 3 months; or deemed unsuitable for the trial by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laryngeal mask airway	laryngeal mask airway and endotracheal tube	In this group, patients use a laryngeal mask airway for intraoperative mechanical ventilation.
endotracheal intubation	laryngeal mask airway and endotracheal tube	In this group, patients use a endotracheal tube for intraoperative mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
PPC	7 days after surgery	The primary outcome is the incidence of a collapsed composite of postoperative pulmonary complications within 7 postoperative days, diagnosed according to Dr Wang's work published on Anesthesiology, 2022 (PMID: 35226725).

Secondary Outcome Measures

Name	Time	Method
extrapulmonary complications	7 days after surgery	extrapulmonary complications according to regular medical reports
severity of PPC	7 days after surgery	Clavien Dindo criteria
diagnosis of PPC	7 days after surgery	Postoperative pulmonary complications are defined by respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia (Diagnosed according to utcome is the incidence of postoperative pulmonary complications within 7 postoperative days, diagnosed according to Anesthesiology, 2022 (PMID: 35226725).