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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
- 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.
- 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.
Typ studiów
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Suresnes, Francja, 92150
- Morgan LE GUEN, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Custom
patient with installation on an infused airbag until a comfortable position is reached
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patient with personalized installation until a comfortable position is reached
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Brak interwencji: Control
Jackson's amended position with placement of a 6 cm high cushion under the patient's head
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: 1 day
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the proportion of orotracheal intubations for which third party assistance is required
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1 day
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Assessment of the effect of patient positioning on the quality of exposure during intubation
Ramy czasowe: 1 day
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1 day
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Determination of the most frequent complementary resettlement actions
Ramy czasowe: 1 day
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1 day
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Assessment of the quality of manual ventilation before intubation (peroxygenation)
Ramy czasowe: 1 day
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1 day
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Assessment of the frequency and severity of complications of intubation
Ramy czasowe: 2 days
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The complications of intubation was defined by the pharyngeal pain the day after surgery, dysphonia, an irritative cough reported by the patient and atelectasis.
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2 days
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Assessment of patient comfort and the doctor's opinion on the technique
Ramy czasowe: 1 day
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The doctor's opinion on the technique was defined by the regard to pre-oxygenation, peroxygenation, and intubation.
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1 day
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Safety assessment of the technique
Ramy czasowe: 1 day
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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.
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1 day
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2020_0030
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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