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

Pulmonary Complication Clinical Trial

Official title:

Comparison of Supraglottic Airway and Tracheal Intubation on Postoperative Pulmonary Complications Among High-risk Geriatric Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391333
• Other study ID #: POLMA2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 5, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2210
• Est. completion date: June 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Complication

Intervention

Device:
• laryngeal mask airway and endotracheal tube
The two most commonly used devices for mechanical ventilation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPC	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).	7 days after surgery
Secondary	extrapulmonary complications	extrapulmonary complications according to regular medical reports	7 days after surgery
Secondary	severity of PPC	Clavien Dindo criteria	7 days after surgery
Secondary	diagnosis of PPC	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).	7 days after surgery