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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Not yet enrolling

Conditions

Pulmonary Complication

Treatments

Device: laryngeal mask airway and endotracheal tube

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

2,210 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2,210 participants in 2 patient groups, including a placebo group

laryngeal mask airway
Active Comparator group
Description:
In this group, patients use a laryngeal mask airway for intraoperative mechanical ventilation.
Treatment:
Device: laryngeal mask airway and endotracheal tube
endotracheal intubation
Placebo Comparator group
Description:
In this group, patients use a endotracheal tube for intraoperative mechanical ventilation.
Treatment:
Device: laryngeal mask airway and endotracheal tube

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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