NCT03542032

Brief Summary

To compare the jaw thrust maneuver with the conventional technical methods to place the I-Gel laryngeal mask

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 5, 2019

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

May 18, 2018

Last Update Submit

July 2, 2019

Conditions

Keywords

i-geljaw-thrust

Outcome Measures

Primary Outcomes (2)

  • insertion time

    Time for successful i-gel insertion

    2 minutes

  • successful insertion number

    successful insertion number

    2 minutes

Study Arms (2)

jaw-thrust

OTHER

the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) This groups will record the insertion time of i-gel, number of trials, operative time, placement complications. Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed. Patients' postoperative sore throat will be questioned and recorded.

Other: i-gel placement maneuvers

classic group

NO INTERVENTION

In the classic group, the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place. This groups will record the insertion time of i-gel, number of trials, operative time, placement complications. Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed. Patients' postoperative sore throat will be questioned and recorded.

Interventions

the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) In the classic maneuver , the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place.

jaw-thrust

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 and 75 years
  • American Society of Anesthesiologists I, II or III

You may not qualify if:

  • Those with anatomical disorders related to the upper airway
  • lung disease
  • gastric regurgitation
  • Those who have had lung infection in the last 3 weeks
  • Supraglottic airway vehicle not settled
  • Those who are hired for any reason
  • EtCO2\> 45
  • American Society of Anesthesiologists 4 or 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training Research Hospital

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 18, 2018

First Posted

May 31, 2018

Study Start

June 1, 2018

Primary Completion

March 30, 2019

Study Completion

June 30, 2019

Last Updated

July 5, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations