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

NCT02240901 | Completed DMC

• 2 other identifiers: EHBH2013-003-005EHBHKY20I3-003-005
• Study Type: interventional
• Target: 2,900
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laryngeal mask airway; endotracheal intubation; postoperative pulmonary complications; elderly patients

Outcome Measures

Primary Outcomes (1)

• The occurrence of postoperative pulmonary complications

  five-category scale to assess the pulmonary outcomes: 0, no pulmonary complications 1, either one of the following: cough, minor lung atelectasis, dyspnea; 2, cough and sputum, bronchospasm, hypoxemia, atelectasis, hypercapnia; 3, pleural effusion, suspected pneumonia, diagnosed pneumonia, pneumothorax, diagnosed pneumonia, pneumothorax, non-invasive or invasive mechanical ventilation\<48hr 4, respiratory failure.

  before discharge

Secondary Outcomes (8)

• mortality

  before discharge

• ICU admission rate

  before discharge

• Hospitalization days

  before discharge

• PACU stay

  before discharge

• Blood and sputum culture

  before discharge

Study Arms (2)

Laryngeal mask airway

EXPERIMENTAL

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

Device: Laryngeal mask airway（LMA）

Endotracheal intubation group（ETI）

EXPERIMENTAL

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

Device: Endotracheal intubation（ETI）

Interventions

Laryngeal mask airway（LMA） DEVICE

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

Laryngeal mask airway

Endotracheal intubation（ETI） DEVICE

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

Endotracheal intubation group（ETI）

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70
• Elective surgery
• BMI ≤ 35 kg/m2
• Provision of signed informed consent

You may not qualify if:

• emergency surgery
• have anticipated difficult intubation
• have a broken or unstable cervix
• have laryngeal disease
• are at high risk of aspiration (gastroesophageal reflux disease, full stomach)
• are unable to cooperate for any reason, such as inability to speak or understand, mental disease, or inability to go to the clinics
• have taken experimental drugs in the preceding 3 months or joined another clinical trial
• did not provide informed consent or have withdrawn consent
• are evaluated by the investigator as unsuitable for this trial

Sponsors & Collaborators

• RenJi Hospital: lead
• Fudan University: collaborator
• Shanghai Changzheng Hospital: collaborator
• Shanghai First Maternity and Infant Hospital: collaborator
• Huadong Hospital: collaborator
• West China Hospital: collaborator
• Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• Shanghai Jiading District Central Hospital: collaborator
• Shanghai Pudong New Area Gongli Hospital: collaborator
• Shanghai Huangpu District Central Hospital: collaborator
• Shanghai Fengxian District Central Hospital: collaborator
• People's Hospital of Pudong New District: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Wuxi No. 2 People's Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

Location

Related Publications (14)

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• Zhu L, Shi X, Yin S, Yin J, Zhu Z, Gao X, Jiao Y, Yu W, Yang L. Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial. Trials. 2019 May 8;20(1):260. doi: 10.1186/s13063-019-3351-2.

  PMID: 31068221 DERIVED

Study Officials

• Weifeng Yu, Ph.D.

  Department of Anesthesiology Renji Hospital, Shanghai Jiaotong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: August 23, 2014
• First Posted: September 16, 2014
• Study Start: August 3, 2016
• Primary Completion: January 23, 2020
• Study Completion: April 15, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

CN (1)