Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres

NCT02852135 | Completed DMC

• 1 other identifier: LMA-lateral-laparoscopic
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages over the classic LMA.Several publications have reported the successful, safe use of Laryngeal Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no studies that have examined the application of LMA in patients during lateral positioned laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general anesthesia.

Conditions

Urologic Surgical Procedures

Keywords

Laryngeal Mask Airway; lateral position; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group

  The equilibrating airway pressure was recorded when an audible leak occurred over the mouth.

  intraoperative

Secondary Outcomes (2)

• Ventilatory efficiency scores for the LMAs

  intraoperative

• Adverse effects in two groups

  intraoperative

Study Arms (2)

LMA Proseal group

EXPERIMENTAL

The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Prosealgroup,LMA Proseal was inserted into each patient after anesthesia induction.

Device: LMA Proseal

LMA Supreme group

EXPERIMENTAL

The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Supreme group,LMA Supreme was inserted into each patient after anesthesia induction.

Device: LMA Supreme

Interventions

LMA Proseal DEVICE

After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium,LMA Proseal was inserted and cuff inflated in each group.

LMA Proseal group

LMA Supreme DEVICE

After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium ，LMA Supreme was inserted and cuff inflated in each group.

LMA Supreme group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients belong to ASA physical status grade I and Ⅲ, aged above 18 years and body weight less than 30 kg/m2,who underwent elective laparoscopic urology surgery in the lateral position.

You may not qualify if:

• The patients with anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Officials

• Liu Yi, D.M

  Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 9, 2017

Record last verified: 2017-03