NCT04959149

Brief Summary

Introduction : In a typical endotracheal intubation, the patient is in the supine position, with the anesthetist standing behind his head and with adequate access to the head and neck of the patient. However, there are several situations, where traditional intubation is very difficult or even impossible. In immobilised trauma victims, with limited access to the head, suspected cervical spine injury or in sitting positioned patient an intubation performed by a person standing in front of a patient might be the only chance of airway management. Moreover, in case of general anesthesia in bariatric patients, face-to-face (inverse) method is increasingly being considered due to upper body elevation position, recommended in this group of patients. This was a parallel randomised controlled trial in patients scheduled for planned sleeve gastrectomy in Barlicki University Hospital, Lodz, Poland. Randomization and allocation to trial group were carried out by drawing envelopes by independent observer before a procedure. Randomized and recruited participants were 76 adults (typical intubation n= 36, face-to-face intubation n=40). Main outcome was a time of intubation using Airtraq video laryngoscope measured by independent assistant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

December 28, 2020

Last Update Submit

June 9, 2022

Conditions

Intubation;DifficultObesity, Morbid

Keywords

obesityintubationvideolaryngoscope

Outcome Measures

Primary Outcomes (1)

  • time of intubation

    time of intubation measured from grabbing the device to confirming the correct placement using EtCO2

    during the intervention/procedure

Secondary Outcomes (1)

  • effectiveness

    during the intervention/procedure

Other Outcomes (1)

  • complications

    immediately after the intervention/procedure

Study Arms (2)

face-to-face intubation

EXPERIMENTAL

intubation approach from front of the patient

Device: AirTraq videolaryngoscope

standard position intubation

ACTIVE COMPARATOR

intubation approach from behind the head of the patient

Device: AirTraq videolaryngoscope

Interventions

AirTraq videolaryngoscopeDEVICE

intubation of morbidly obese patient using Airtraq videolaryngoscope

face-to-face intubationstandard position intubation

Eligibility Criteria

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

You may qualify if:

  • BMI \> 40 kg.m-2
  • Patients qualified for planned sleeve gastrectomy.
  • Patients of I and II class of ASA scale.
  • Patients without history of difficult intubation.

You may not qualify if:

  • Patients in life threatening states.
  • Patients of III, IV, V and VI class of ASA scale.
  • History of difficult intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Lodz, Poland

Lodz, 90-153, Poland

Location

Related Publications (2)

  • Arslan ZI, Alparslan V, Ozdal P, Toker K, Solak M. Face-to-face tracheal intubation in adult patients: a comparison of the Airtraq, Glidescope and Fastrach devices. J Anesth. 2015 Dec;29(6):893-8. doi: 10.1007/s00540-015-2052-6. Epub 2015 Jul 29.

    PMID: 26219732BACKGROUND

  • Jeong H, Chae M, Seo H, Yi JW, Kang JM, Lee BJ. Face-to-face intubation using a lightwand in a patient with severe thoracolumbar kyphosis: a case report. BMC Anesthesiol. 2018 Jul 21;18(1):92. doi: 10.1186/s12871-018-0556-y.

    PMID: 30031381BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tomasz Gaszynski

    Medical University of Lodz, Poland

    PRINCIPAL INVESTIGATOR

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
professor of anaesthesia

Study Record Dates

First Submitted

December 28, 2020

First Posted

July 13, 2021

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 30, 2020

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

on request

Locations

PL(1)