CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,900 enrolled
Drug / intervention
Laryngeal mask airway(LMA) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02240901
NCT02240901N/ACompleted

Effectiveness and Pulmonary Complications of Peri-Operative Laryngeal Mask Airway Used in Elderly Patients(POLMA-EP Trial): a Multi-center Randomized Controlled Clinical Trial

RenJi Hospital·interventional·Posted Sep 16, 2014·Updated Oct 29, 2020

In Brief

A clinical study evaluating Laryngeal mask airway(LMA) and Endotracheal intubation(ETI) for Complications and Surgery. Completed, enrolled 2,900 participants across 1 site.

Detailed Summary

Perioperative airway management is a top priority of anesthesiologists in daily work, and endotracheal intubation (ETI) is considered as the gold standard for providing safe glottic seal,effective ventilation and oxygen supplement during general anesthesia. But ETI related complications such as concomitant hemodynamic responses, damage to the oropharyngeal structures at insertion and postoperative sore throat. Laryngeal mask airway(LMA) for the anesthesia management brings new choice with invasive, lighter cardiovascular reaction and many other advantages, particularly suited to short and minimally invasive surgery. But LMA increased the risk of gastrointestinal reflux aspiration than using ETI and it may resulted in intolerance in high airway pressure, especially in elderly patients with increased lung compliance or reduced airway resistance. Furthermore, LMA could not entirely prevent the occurrence of postoperative sore throat and hoarse. To sum up, it is necessary to carry out a multicenter clinical trial to clarify the safety of LMA in elderly patients. The investigators protocol will focus on the incidence of postoperative pulmonary complications (PPCs) when applications of LMA and ETI in elderly patients.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 16, 2014
Enrollment StartAug 3, 2016
Primary CompletionJan 23, 2020
Study CompletionApr 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.8 years ago

Interventions

Laryngeal mask airway(LMA)device

Laryngeal mask airway(LMA) is used to maintain mechanical ventilation during intra-operative

Endotracheal intubation(ETI)device

Endotracheal intubation group(ETI)is used to maintain mechanical ventilation during intra-operative