A Multi-center Randomized Clinical Trial About Using LMA or ETI in Elderly Patients

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.

Conditions

• Complications
• Surgery

Interventions

DEVICE

Laryngeal mask airway（LMA）

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

DEVICE

Endotracheal intubation（ETI）

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

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• Huadong Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator OTHER

• Shanghai Jiading District Central Hospital

  collaborator OTHER

• Shanghai Pudong New Area Gongli Hospital

  collaborator OTHER

• Shanghai Huangpu District Central Hospital

  collaborator UNKNOWN

• Shanghai Fengxian District Central Hospital

  collaborator OTHER

• People's Hospital of Pudong New District

  collaborator UNKNOWN

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Wuxi No. 2 People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• RenJi Hospital

  lead OTHER

Principal Investigators

• Weifeng Yu, Ph.D. · Department of Anesthesiology Renji Hospital, Shanghai Jiaotong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-03

Primary Completion

2020-01-23

Completion

2020-04-15

Countries

• China

Study Locations