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

NCT ID: NCT01909297

Last Updated: 2013-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-07-31

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).

Conditions

Airway Complication of Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ProSeal LMA

Supraglottic airway device

Group Type: ACTIVE_COMPARATOR

PROSEAL LMA

Intervention Type: DEVICE

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

suprema LMA

Supraglottic airway device

Group Type: ACTIVE_COMPARATOR

SUPREMA LMA

Intervention Type: DEVICE

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

I-gel LMA

Supraglottic airway device

Group Type: ACTIVE_COMPARATOR

I-GEL LMA

Intervention Type: DEVICE

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

Interventions

PROSEAL LMA

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

Intervention Type: DEVICE

SUPREMA LMA

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

Intervention Type: DEVICE

I-GEL LMA

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18- 60 YEARS

Exclusion Criteria

• ASA 3-4 patients
• BMI 40

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Mukadder Sanli

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mukadder sanli, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Prof Dr

Locations

Inonu University

Malatya, Turkey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 20640137 (View on PubMed)

Other Identifiers

2011/188

Identifier Type: -

Identifier Source: org_study_id