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Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients

Primary Purpose

Airway Complication of Anaesthesia

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

PROSEAL LMA

SUPREMA LMA

I-GEL LMA

About this trial

This is an interventional prevention trial for Airway Complication of Anaesthesia focused on measuring airway management

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18- 60 YEARS

Exclusion Criteria:

ASA 3-4 patients
BMI 40

Sites / Locations

Inonu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

ProSeal LMA

suprema LMA

I-gel LMA

Arm Description

Supraglottic airway device

Outcomes

Primary Outcome Measures

change of oropharyngeal leak pressure

During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)

Secondary Outcome Measures

easiness of insertion of the device

During insertion, easiness of the devices were evaluated by a scale

Full Information

NCT ID

NCT01909297

First Posted

June 21, 2013

Last Updated

July 25, 2013

Sponsor

Inonu University

1. Study Identification

Unique Protocol Identification Number

NCT01909297

Brief Title

Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients

Official Title

Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients Undergoing Gynaecological Laparoscopic Surgery With Oropharyngeal Leak Pressure

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Inonu University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators aimed to compare of the i-gel, supreme and proseal laryngeal mask airways in paralysed patients undergoing gynaecological laparoscopic surgery with oropharyngeal leak pressure. The investigators also studied their relative ease of insertion, time to insertion and complications of use as secondary outcome measures.

Detailed Description

A total of 105 patients scheduled for elective gynaecological laparoscopic procedures in our Inonu University Medical Faculty Hospital were recruited.They were equally randomized into three groups: PLMA, supreme and i-gel groups. All three devices were compared with regard to oropharyngeal leak pressure, number and duration of insertion attempts and complications of airway. Oropharyngeal leak pressure will evaluate including to start,trendelenburg and postoperative at period. Fiberoptic evaluation of the LMA's position were performed after successful insertion and determination of the airway pressures. After one hour patients were evaluated by a blinded independent observer for postoperative complications ( sore throat, dysphonia and dysphagia).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Airway Complication of Anaesthesia

Keywords

airway management

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ProSeal LMA

Arm Type

Active Comparator

Arm Description

Supraglottic airway device

Arm Title

suprema LMA

Arm Type

Active Comparator

Arm Description

Supraglottic airway device

Arm Title

I-gel LMA

Arm Type

Active Comparator

Arm Description

Supraglottic airway device

Intervention Type

Device

Intervention Name(s)

PROSEAL LMA

Intervention Description

Size 3,4 or 5 supraglottic device with orogastric drainage tube

Intervention Type

Device

Intervention Name(s)

SUPREMA LMA

Intervention Description

Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube

Intervention Type

Device

Intervention Name(s)

I-GEL LMA

Intervention Description

Size 3,4,5 disposable supraglottic device with noninflatable cuff

Primary Outcome Measure Information:

Title

change of oropharyngeal leak pressure

Description

During intraoperative period, oropharyngeal leak pressure was measured at three times (10min, 30 min, and 45 min after insertion of devices)

Time Frame

10min, 30 min ,45 min

Secondary Outcome Measure Information:

Title

easiness of insertion of the device

Description

During insertion, easiness of the devices were evaluated by a scale

Time Frame

2 min

Other Pre-specified Outcome Measures:

Title

postoperative complication

Description

At the second hour of postoperative period, patients will visit and will examine about the complications (sore throat, dysphagia, dysphonia)

Time Frame

2 hour after operation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18- 60 YEARS Exclusion Criteria: ASA 3-4 patients BMI 40

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mukadder sanli, MD

Organizational Affiliation

Assistant Prof Dr

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inonu University

City

Malatya

ZIP/Postal Code

44100

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

20640137

Citation

Singh I, Gupta M, Tandon M. Comparison of Clinical Performance of I-Gel with LMA-Proseal in Elective Surgeries. Indian J Anaesth. 2009 Jun;53(3):302-5.

Results Reference

result

Learn more about this trial

Comparison of the I-gel, Supreme and Proseal LMA in Paralyzed Patients

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