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Does a Customized Intubation Facility Reduce Incidence of Difficulty

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07647718
Acronym
Person-OTI
Enrollment
0
Registered
2026-06-15
Start date
2022-01-05
Completion date
2024-01-12
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orotracheal Intubation

Keywords

AirPal RAMP ™ mattress, McGrathR Mac ™ video laryngoscope

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.

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.

Interventions

PROCEDUREpatient with personalized installation with AirPal RAMP™ mattress

patient with personalized installation until a comfortable position is reached

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 intubation1 daythe proportion of orotracheal intubations for which third party assistance is required

Secondary

MeasureTime frameDescription
Assessment of the effect of patient positioning on the quality of exposure during intubation1 day* 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)
Determination of the most frequent complementary resettlement actions1 day* 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.
Assessment of the quality of manual ventilation before intubation (peroxygenation)1 day* the use of a Guédel cannula; * the number of hands required for ventilation; * the percentage of leakage; * minimal SpO2; * maximum ETCO2.
Assessment of the frequency and severity of complications of intubation2 daysThe complications of intubation was defined by the pharyngeal pain the day after surgery, dysphonia, an irritative cough reported by the patient and atelectasis.
Assessment of patient comfort and the doctor's opinion on the technique1 dayThe doctor's opinion on the technique was defined by the regard to pre-oxygenation, peroxygenation, and intubation.
Safety assessment of the technique1 daySafety 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026