NCT05607433

Brief Summary

The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

September 13, 2019

Last Update Submit

November 1, 2022

Conditions

Keywords

assisted intubation

Outcome Measures

Primary Outcomes (1)

  • Total endotracheal intubation time

    tube exchanger intubation time plus endotracheal intubation time

    time of tube exchanger insertion and endotracheal tube insertion

Secondary Outcomes (2)

  • success rate of endotracheal intubation

    1 second after insertion tube exchanger until successful endotracheal intubation

  • Tube exchanger insertion time

    from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea

Other Outcomes (1)

  • postoperative hoarseness of voice

    2 hours postoperative

Study Arms (2)

Air Q ILA group

EXPERIMENTAL

Air Q supraglottic device will be placed in the participants in this group .

Device: cook ®Airway Exchanger Catheter

Ambu AuraGain group

EXPERIMENTAL

Ambu AuraGain supraglottic device will be placed in the participants in this group .

Device: cook ®Airway Exchanger Catheter

Interventions

A tube exchanger is a small calibre , flexible tube used to guide endotracheal intubation through a supraglottic device.

Air Q ILA groupAmbu AuraGain group

Eligibility Criteria

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

You may qualify if:

  • Age : 18 to 60
  • ASA physical status 1 and 2
  • body weight less than 90 kilos
  • Ganzouri airway score less than or equal to 3.

You may not qualify if:

  • Active respiratory or cardiac disease
  • Any expected airway difficulties
  • Craniofacial abnormalities or fractures
  • patients with abnormal coagulation profile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital

Cairo, Elmanial, 11559, Egypt

Location

Related Publications (2)

  • Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.

    PMID: 21320087BACKGROUND
  • Bakker EJ, Valkenburg M, Galvin EM. Pilot study of the air-Q intubating laryngeal airway in clinical use. Anaesth Intensive Care. 2010 Mar;38(2):346-8. doi: 10.1177/0310057X1003800217.

    PMID: 20369770BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
only participants will be masked
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized comparative study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of anesthesia

Study Record Dates

First Submitted

September 13, 2019

First Posted

November 7, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations