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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06391333
Enrollment
2210
Registered
2024-04-30
Start date
2024-05-05
Completion date
2026-06-15
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Complication

Keywords

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

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.

Interventions

DEVICElaryngeal mask airway and endotracheal tube

The two most commonly used devices for mechanical ventilation.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
PPC7 days after surgeryThe 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).

Secondary

MeasureTime frameDescription
extrapulmonary complications7 days after surgeryextrapulmonary complications according to regular medical reports
severity of PPC7 days after surgeryClavien Dindo criteria
diagnosis of PPC7 days after surgeryPostoperative 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026