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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • laryngeal mask airway and endotracheal tube

    Device

    The two most commonly used devices for mechanical ventilation.

Treatment groups

2,210 Participants
are divided into 2 treatment groups
Group A: laryngeal mask airwayActive comparator 1 intervention
Group B: endotracheal intubationPlacebo comparator 1 intervention

Trial outcomes

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).

Time frame
7 days after surgery

Secondary outcomes

1

extrapulmonary complications

extrapulmonary complications according to regular medical reports

Time frame
7 days after surgery
2

severity of PPC

Clavien Dindo criteria

Time frame
7 days after surgery
3

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).

Time frame
7 days after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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