NCT04109898

Brief Summary

Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

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

September 7, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

September 27, 2019

Last Update Submit

February 12, 2021

Conditions

Airway Morbidity

Keywords

airway managementI-gelanaesthesia

Outcome Measures

Primary Outcomes (1)

  • adverse airway events

    All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.

    5 minutes

Secondary Outcomes (1)

  • adverse airway events

    60 minutes

Study Arms (2)

standard I-gel insertion technique

NO INTERVENTION

Investigator will apply the recommended (standard) I-gel insertion technique in patients

Modified I-gel insertion technique

EXPERIMENTAL

Investigator will apply the modified (interventional) I-gel insertion technique in patients

Device: Supraglottic airway device (I-gel) insertion

Interventions

Supraglottic airway device (I-gel) insertionDEVICE

Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.

Modified I-gel insertion technique

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA I and II patients.
  • Age 16 years to 60 years.
  • Patient scheduled for elective surgical procedure.

You may not qualify if:

  • Gastroesophageal reflux disorders
  • Obesity BMI more than 30.
  • Pregnancy
  • Reactive airway disease/asthma
  • Patients with mallampati score III \& IV
  • Anticipated difficult airway
  • Emergent surgery.
  • Known allergic to isoflurane and propofol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Officials

  • dileep kumar, MD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 1, 2019

Study Start

September 7, 2019

Primary Completion

March 15, 2020

Study Completion

March 19, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

PA(1)