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

NCT06391333 | Not Yet Recruiting DMC

• 1 other identifier: POLMA2
• Study Type: interventional
• Target: 2,210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Complication

Keywords

Supraglottic airway; Tracheal intubation; Postoperative pulmonary complications; Geriatric surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• extrapulmonary complications

  7 days after surgery

• severity of PPC

  7 days after surgery

• diagnosis of PPC

  7 days after surgery

Study Arms (2)

laryngeal mask airway

ACTIVE COMPARATOR

In this group, patients use a laryngeal mask airway for intraoperative mechanical ventilation.

Device: laryngeal mask airway and endotracheal tube

endotracheal intubation

PLACEBO COMPARATOR

In this group, patients use a endotracheal tube for intraoperative mechanical ventilation.

Device: laryngeal mask airway and endotracheal tube

Interventions

laryngeal mask airway and endotracheal tube DEVICE

The two most commonly used devices for mechanical ventilation.

endotracheal intubation; laryngeal mask airway

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

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

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 30, 2024
• Study Start: May 5, 2024
• Primary Completion: April 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04