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

9 juni 2026 uppdaterad av: Hopital Foch

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.

Studieöversikt

Detaljerad beskrivning

  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.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Custom
patient with installation on an infused airbag until a comfortable position is reached
patient with personalized installation until a comfortable position is reached
Inget ingripande: Control
Jackson's amended position with placement of a 6 cm high cushion under the patient's head

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 1 day
the proportion of orotracheal intubations for which third party assistance is required
1 day

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assessment of the effect of patient positioning on the quality of exposure during intubation
Tidsram: 1 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)
1 day
Determination of the most frequent complementary resettlement actions
Tidsram: 1 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.
1 day
Assessment of the quality of manual ventilation before intubation (peroxygenation)
Tidsram: 1 day
  • 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
Tidsram: 2 days
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
Tidsram: 1 day
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
Tidsram: 1 day
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

Samarbetspartners och utredare

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Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 januari 2022

Primärt slutförande (Faktisk)

5 januari 2024

Avslutad studie (Faktisk)

12 januari 2024

Studieregistreringsdatum

Först inskickad

6 augusti 2021

Först inskickad som uppfyllde QC-kriterierna

9 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2020_0030

Plan för individuella deltagardata (IPD)

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NEJ

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Nej

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