NCT01909297

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
Last Updated

July 26, 2013

Status Verified

July 1, 2013

Enrollment Period

1 month

First QC Date

June 21, 2013

Last Update Submit

July 25, 2013

Conditions

Airway Complication of Anaesthesia

Keywords

airway management

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • easiness of insertion of the device

    2 min

Other Outcomes (1)

  • postoperative complication

    2 hour after operation

Study Arms (3)

ProSeal LMA

ACTIVE COMPARATOR

Supraglottic airway device

Device: PROSEAL LMA

suprema LMA

ACTIVE COMPARATOR

Supraglottic airway device

Device: SUPREMA LMA

I-gel LMA

ACTIVE COMPARATOR

Supraglottic airway device

Device: I-GEL LMA

Interventions

PROSEAL LMADEVICE

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

ProSeal LMA
SUPREMA LMADEVICE

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

suprema LMA
I-GEL LMADEVICE

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

I-gel LMA

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • YEARS

You may not qualify if:

  • ASA 3-4 patients
  • BMI 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey, 44100, Turkey (Türkiye)

Location

Related 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.

    PMID: 20640137RESULT

Study Officials

  • mukadder sanli, MD

    Assistant Prof Dr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 21, 2013

First Posted

July 26, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

July 26, 2013

Record last verified: 2013-07

Locations

TU(1)