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

Airway Complication of Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909297
• Other study ID #: 2011/188
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: July 25, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18- 60 YEARS

Exclusion Criteria:

• ASA 3-4 patients

• BMI 40

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Airway Complication of Anaesthesia

Intervention

Device:
• PROSEAL LMA
Size 3,4 or 5 supraglottic device with orogastric drainage tube
• SUPREMA LMA
Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube
• I-GEL LMA
Size 3,4,5 disposable supraglottic device with noninflatable cuff

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative complication	At the second hour of postoperative period, patients will visit and will examine about the complications (sore throat, dysphagia, dysphonia)	2 hour after operation	Yes
Primary	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)	10min, 30 min ,45 min	Yes
Secondary	easiness of insertion of the device	During insertion, easiness of the devices were evaluated by a scale	2 min	Yes