Does a Customized Intubation Facility Reduce Incidence of Difficulty

NCT07647718 | Withdrawn

• 1 other identifier: 2020_0030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The idea of this study is to demonstrate that the position of the head at a comfort height spontaneously expressed by the patient, between Jackson's amended position or Ramp position, significantly improves the quality of the intubation gesture. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress. Thus the investigators can assume that the appropriate positioning and use of a video laryngoscope (McGrathR Mac) places the patient in the best anatomical configuration to breathe and, indirectly to facilitate control of the airways, especially for those with a risk of difficult airway management.

Conditions

Orotracheal Intubation

Keywords

AirPal RAMP ™ mattress; McGrathR Mac ™ video laryngoscope

Outcome Measures

Primary Outcomes (1)

• the impact of a custom installation versus a conventional Jackson amended installation with a 6-centimeter cushion under the patient's head to facilitate orotracheal intubation

  the proportion of orotracheal intubations for which third party assistance is required

  1 day

Secondary Outcomes (6)

• Assessment of the effect of patient positioning on the quality of exposure during intubation

  1 day

• Determination of the most frequent complementary resettlement actions

  1 day

• Assessment of the quality of manual ventilation before intubation (peroxygenation)

  1 day

• Assessment of the frequency and severity of complications of intubation

  2 days

• Assessment of patient comfort and the doctor's opinion on the technique

  1 day

Study Arms (2)

Custom

EXPERIMENTAL

patient with installation on an infused airbag until a comfortable position is reached

Procedure: patient with personalized installation with AirPal RAMP™ mattress

Control

NO INTERVENTION

Jackson's amended position with placement of a 6 cm high cushion under the patient's head

Interventions

patient with personalized installation with AirPal RAMP™ mattress PROCEDURE

patient with personalized installation until a comfortable position is reached

Custom

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women over 18 and under 80;
• Must undergo general anesthesia with oral intubation using a standard intubation probe;
• Can be contacted directly by telephone if they are patients treated in outpatient surgery;
• Having signed a consent form;
• Being affiliated to a Health Insurance scheme.

You may not qualify if:

• pregnant or breastfeeding patients;
• patients for whom the surgery requires the placement of a double-lumen tube;
• patients requiring rapid sequence induction;
• patients for whom induction cannot be carried out by the sufentanil, propofol, atracurium or rocuronium sequence.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Morgan LE GUEN, PhD

Suresnes, 92150, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: June 15, 2026
• Study Start: January 5, 2022
• Primary Completion: January 5, 2024
• Study Completion: January 12, 2024
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)