NCT03743831

Brief Summary

News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during intubation while limiting mouth opening and cervical hyper extension, but also dental trauma and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time the apnea time. After a review of the literature, it has been proven that its use reduces haemodynamic changes during intubation. But these studies have been realized only in very particular patients (obese, heart failure) and with induction protocols that are not used routinely in our operating theaters. Reasons why it decided to carry out this study, on the one hand to find these results and especially to be able to extend them to the whole population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

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

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

November 14, 2018

Last Update Submit

March 25, 2020

Conditions

Orotracheal Intubation

Keywords

Laryngoscopy directLaryngoscopy indirect by Airtraqhemodynamic changesside effects

Outcome Measures

Primary Outcomes (1)

  • change from intubation mean blood pressure at 1 min after intubation

    between the values before intubation (T0) and 1min after intubation.

Secondary Outcomes (7)

  • Frequency of patients with hemodynamic reaction post intubation (minimal variation of mean blood pressure or heart rate of 20%

    between values before intubation and 1, 2, 5, 10 minutes after intubation.

  • Variation of blood pressure (PAM)

    between the values before intubation (T0) and 2, 5 and 10 minutes of intubation

  • Variation of heart rate (HR)

    between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation

  • Mean of the arterial blood pressure and heart rate

    before intubation and at 1,2,5 and 10 minutes from intubation.

  • Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon

    at 1 min after intubation

  • +2 more secondary outcomes

Study Arms (2)

orotracheal intubation direct

OTHER
Device: orotracheal intubation by direct laryngoscopy

orotracheal intubation indirect

OTHER
Device: orotracheal intubation by indirect laryngoscopy

Interventions

orotracheal intubation by direct laryngoscopyDEVICE

Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch

orotracheal intubation direct
orotracheal intubation by indirect laryngoscopyDEVICE

orotracheal intubation by indirect laryngoscopy by Airtraq

orotracheal intubation indirect

Eligibility Criteria

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

You may qualify if:

  • Specific medical conditions: ASA 1 or 2
  • Patient having given written consent to participate in the category 2 trial
  • Intubation realized by experienced person
  • Social Insured Patient
  • Patient willing to comply with all procedures of the study and its duration

You may not qualify if:

  • Demographic characteristics: minor, over 65
  • Medical history: history of difficult intubation, hypertension
  • Lille intubation score greater than or equal to 7
  • Treatments in progress: Beta taking blocking the day of the operation.
  • Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Study Officials

  • Elsa Jozefowicz, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

December 4, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

FR(1)