NCT04680169

Brief Summary

This trial compares two different second generation supraglottic airway devices (AuraGain and I-gel) used as a conduit for bronchoscopic tracheal intubation during continuous oxygenation in order tο determine time to successful tracheal intubation and ease of use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

First Submitted

Initial submission to the registry

December 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2021

Completed
Last Updated

June 21, 2021

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 17, 2020

Last Update Submit

June 18, 2021

Conditions

Airway Management

Keywords

IntubationBronchoscopicSupraglottic airway deviceI-gelAuraGainFlexibleFiberoptic

Outcome Measures

Primary Outcomes (1)

  • Total time for airway management

    Total time from reaching the SGA with hands to ended bronchoscopic tracheal intubation confirmed by the end of first curve on capnography

    Up to study completion, an average of 4 months

Secondary Outcomes (4)

  • Time to placement of SGA

    Up to study completion, an average of 4 months

  • Time to trans-device tracheal intubation

    Up to study completion, an average of 4 months

  • Number of attempts needed for correct placement of SGA

    Up to study completion, an average of 4 months

  • Number of attempts needed for correct intubation

    Up to study completion, an average of 4 months

Other Outcomes (6)

  • Reason for failed intubation

    Up to study completion, an average of 4 months

  • Feeling of resistance during tracheal intubation

    Up to study completion, an average of 4 months

  • Feasibility of SGA placement

    Up to study completion, an average of 4 months

  • +3 more other outcomes

Study Arms (2)

Group A: Bronchoscopic intubation using AuraGain LMA as conduit

ACTIVE COMPARATOR

A group of 50 patients randomly allocated to bronchoscopic intubation using AuraGain

Device: Bronchoscopic intubation through AuraGain LMA

Group B: Bronchoscopic intubation with I-gel SGA as conduit

ACTIVE COMPARATOR

A group of 50 patients randomly allocated to bronchoscopic intubation using I-gel

Device: Bronchoscopic intubation through I-gel SGA

Interventions

Bronchoscopic intubation through AuraGain LMADEVICE

Comparing two different SGAs as conduit for bronchoscopic tracheal intubation

Group A: Bronchoscopic intubation using AuraGain LMA as conduit
Bronchoscopic intubation through I-gel SGADEVICE

Comparing two different SGAs as conduit for bronchoscopic tracheal intubation

Group B: Bronchoscopic intubation with I-gel SGA as conduit

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for a non-acute ENT, gynaecological, gastrointestinal or orthopaedic surgical procedure for which general anaesthesia including oral intubation with an endotracheal tube will be provided

You may not qualify if:

  • Age\<18 years
  • Inter-incisional distance \<30mm
  • Pregnant and BMI\>40kg/m2
  • ASA physical status classification system grade \>3
  • Earlier laryngeal or pharyngeal surgery
  • Increased risk of aspiration (e.g. nasogastric tube inserted, planned Rapid Sequence Induction)
  • Informed consent cannot be obtained
  • Patients with stridor
  • Patients with hypoxemia defines by saturation \<90 without oxygen at arrival to the operating room
  • Use of oxygen supply at home
  • Need of one of the following special endotracheal tubes for scheduled surgery: neural integrity monitor (NIM) electromyogram (EMG) tracheal tubes, wire tubes
  • Patients scheduled for any awake approach to secure the airway e.g. awake videolaryngoscopy, awake fiberoptic bronchoscope intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Study Officials

  • Charlotte V Rosenstock, Ph.d

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 22, 2020

Study Start

January 18, 2021

Primary Completion

May 4, 2021

Study Completion

May 4, 2021

Last Updated

June 21, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)