NCT02877940

Brief Summary

The Aim of the study is to compare the clinical performance of p-LMA, i-gel and LTS-D in terms of the efficacy and safety in anaesthetized patient on Mechanical ventilation undergoing elective surgical procedure.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

August 17, 2016

Last Update Submit

August 20, 2016

Conditions

Airway Morbidity

Keywords

ProSeal LMALTS-Di-gel

Outcome Measures

Primary Outcomes (1)

  • Number of Insertion attempts

    10 mins

Secondary Outcomes (5)

  • Grading of insertion of device by Easy or Difficult

    10 min

  • Time taken for placement of device

    10 min

  • Airway sealing pressure

    10 min

  • Number of attempts of gastric tube placement

    20 min

  • Complication

    120 min

Study Arms (3)

ProSeal Laryngeal mask airway

ACTIVE COMPARATOR

ProSeal will be inserted in mechanically ventilated patients undergoing elective surgeries.

Device: ProSeal Laryngeal mask airway

Laryngeal Tube Suction- Disposable

ACTIVE COMPARATOR

LTS-D will be inserted in mechanically ventilated patients undergoing elective surgeries.

Device: Laryngeal Tube Suction- Disposable

Group I

ACTIVE COMPARATOR

i-gel will be inserted in mechanically ventilated patients undergoing elective surgeries..

Device: i-gel

Interventions

ProSeal Laryngeal mask airwayDEVICE

ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.

ProSeal Laryngeal mask airway
Laryngeal Tube Suction- DisposableDEVICE

LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.

Laryngeal Tube Suction- Disposable
i-gelDEVICE

i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.

Group I

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anaesthesiologists (ASA) class I/II.
  • Age 20-60years of either sex.
  • Weight between 40-60 kg of either sex.
  • Elective Surgical procedures of duration of 1-1½ hour with no need for endotracheal intubation.

You may not qualify if:

  • Patient with risk factors for difficult airway. (Mouth opening of \<2cm, Mallampati class 4, limited neck extension, history of previous difficult intubation)
  • Any known pulmonary and cardiovascular diseases.
  • Risk of aspiration. (Full stomach, hiatus hernia, gastro-oesophageal reflex disease, emergency surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Geeta Bhandari, MD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 24, 2016

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share