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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Suresnes, Frankrike, 92150
- Morgan LE GUEN, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: Control
Jackson's amended position with placement of a 6 cm high cushion under the patient's head
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of the effect of patient positioning on the quality of exposure during intubation
Tidsramme: 1 day
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1 day
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Determination of the most frequent complementary resettlement actions
Tidsramme: 1 day
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1 day
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Assessment of the quality of manual ventilation before intubation (peroxygenation)
Tidsramme: 1 day
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1 day
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Assessment of the frequency and severity of complications of intubation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2020_0030
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