Does a Customized Intubation Facility Reduce Incidence of Difficulty (Person-OTI)

Does a Customized Intubation Facility Reduce Incidence of Difficulty: Randomized Multicenter Trial?

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.

Study Overview

• Status: Withdrawn
• Conditions: Orotracheal Intubation
• Intervention / Treatment: Procedure: patient with personalized installation with AirPal RAMP™ mattress

Detailed Description

1. Position for orotracheal intubation The period preceding the administration of anesthetic agents is essential to ensure a satisfactory oxygen supply (pre-oxygenation). Then, once loss of consciousness is achieved, an interface (oral intubation probe) is put in place to allow mechanical ventilation during the procedure. This phase can be marked by a more or less expected difficulty depending on the risk factors presented by the patient. Thus an Arne score> 11 is predictive of a potential difficulty which may lead to an alternative technique being proposed. Simple techniques also exist in the patient setup to reduce the incidence of difficulties. Among them, the placement of a cushion under the head with a slight extension of the head of 20 ° (Jackson's amended position) is recommended because it allows to obtain the alignment of the posterior pharyngeal and glottic spaces. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress.

   This optimization of the position according to the patient, between Jackson's amended position or Ramp position, opens up the prospect of defining an optimal position personalized to each patient. Thus, it can be assumed that the appropriate positioning places the patient in the best anatomical configuration for breathing and, indirectly, to facilitate control of the airways.

2. Video laryngoscope The use of a video laryngoscope (McGrathR Mac) is becoming widespread in anesthesia, especially for the management of patients at risk of difficult airway management. This device by the video support at the end of the blade provides a better visualization of the glottic orifice.
3. The hypothesis of this research The idea of this study is to demonstrate that the position of the head at a height of comfort spontaneously expressed by the patient significantly improves the quality of the intubation procedure.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Morgan LE GUEN, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• pregnant or breastfeeding patients;
• patients with a predicted difficulty in mask ventilation or intubation according to the assessment of the doctor who performs the clinical examination prior to inclusion (Arne score ≥ 11) or the one who takes care of the patient in the block operative;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Custom; patient with installation on an infused airbag until a comfortable position is reached	Procedure: patient with personalized installation with AirPal RAMP™ mattress; patient with personalized installation until a comfortable position is reached
No Intervention: Control; Jackson's amended position with placement of a 6 cm high cushion under the patient's head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the effect of patient positioning on the quality of exposure during intubation	the duration of the intubation;; the quality of visualization of the glottis;; failure of intubation defined by reexposure, by esophageal intubation;; the calculation of the Intubation Difficulty Scale (or IDS)	1 day
Determination of the most frequent complementary resettlement actions	the ideal position chosen by the patient (and measured) before the start of the procedure;; the patient's position (measured) when the intubation is successful. The intubation time will be correlated with these measurements and the angles that will be deduced from them;; additional techniques used at the time of intubation.	1 day
Assessment of the quality of manual ventilation before intubation (peroxygenation)	the use of a Guédel cannula;; the number of hands required for ventilation;; the percentage of leakage;; minimal SpO2;; maximum ETCO2.	1 day
Assessment of the frequency and severity of complications of intubation	The complications of intubation was defined by the pharyngeal pain the day after surgery, dysphonia, an irritative cough reported by the patient and atelectasis.	2 days
Assessment of patient comfort and the doctor's opinion on the technique	The doctor's opinion on the technique was defined by the regard to pre-oxygenation, peroxygenation, and intubation.	1 day
Safety assessment of the technique	Safety was evaluated by the occurrence of a fall of the head, occurrence of a fall of the patient, accidental extubation, the incidence of arterial oxygen desaturation, the lowest arterial oxygen saturation and the perception of difficulty in intubation.	1 day

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): January 12, 2024

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: AirPal RAMP ™ mattress; McGrathR Mac ™ video laryngoscope
• Other Study ID Numbers: 2020_0030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No