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

NCT ID: NCT06391333

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-05
• Study Completion Date: 2026-06-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

laryngeal mask airway

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

Group Type: ACTIVE_COMPARATOR

laryngeal mask airway and endotracheal tube

Intervention Type: DEVICE

The two most commonly used devices for mechanical ventilation.

endotracheal intubation

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

Group Type: PLACEBO_COMPARATOR

laryngeal mask airway and endotracheal tube

Intervention Type: DEVICE

The two most commonly used devices for mechanical ventilation.

Interventions

laryngeal mask airway and endotracheal tube

The two most commonly used devices for mechanical ventilation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

POLMA2

Identifier Type: -

Identifier Source: org_study_id