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

Sponsor

Inonu University (Other)

Overall Status

Completed

CT.gov ID

NCT01909297

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

17.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Complication of Anaesthesia	Device: PROSEAL LMA Device: SUPREMA LMA Device: I-GEL LMA	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ProSeal LMA Supraglottic airway device	Device: PROSEAL LMA Size 3,4 or 5 supraglottic device with orogastric drainage tube
Active Comparator: suprema LMA Supraglottic airway device	Device: SUPREMA LMA Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube
Active Comparator: I-gel LMA Supraglottic airway device	Device: I-GEL LMA Size 3,4,5 disposable supraglottic device with noninflatable cuff

Arm

Intervention/Treatment

Active Comparator: ProSeal LMA

Supraglottic airway device

Device: PROSEAL LMA

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

Active Comparator: suprema LMA

Supraglottic airway device

Device: SUPREMA LMA

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

Active Comparator: I-gel LMA

Supraglottic airway device

Device: I-GEL LMA

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

Outcome Measures

Primary Outcome Measures

change of oropharyngeal leak pressure [10min, 30 min ,45 min]
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 [2 min]
During insertion, easiness of the devices were evaluated by a scale

Other Outcome Measures

postoperative complication [2 hour after operation]
At the second hour of postoperative period, patients will visit and will examine about the complications (sore throat, dysphagia, dysphonia)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

18- 60 YEARS

Exclusion Criteria:

ASA 3-4 patients
BMI 40

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inonu University	Malatya		Turkey	44100

Sponsors and Collaborators

Inonu University

Investigators

Principal Investigator: mukadder sanli, MD, Assistant Prof Dr

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mukadder Sanli, assistant professor, Inonu University

ClinicalTrials.gov Identifier:

NCT01909297

Other Study ID Numbers:

2011/188

First Posted:

Jul 26, 2013

Last Update Posted:

Jul 26, 2013

Last Verified:

Jul 1, 2013

Keywords provided by Mukadder Sanli, assistant professor, Inonu University

airway management

Additional relevant MeSH terms:

Paralysis

Study Results

No Results Posted as of Jul 26, 2013