Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) (MUUR)
Comparison of Two Laryngoscopes: Single-use Device Laryngobloc ® (SU) Versus Reusable Handle With Disposable Metal Blade (R) : Quality of Laryngoscopy and Bacterial Contamination of the Handle
Studieöversikt
Status
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Alsace
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Strasbourg cedex, Alsace, Frankrike, 67098
- Rekrytering
- Hopitaux Universitaires de Strasbourg
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Underutredare:
- Simone MANGEANT, MD
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Underutredare:
- Nadia DHIF, MD
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Underutredare:
- Florin DIMACHE, MD
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Underutredare:
- Nathalie STOJEBA, MD
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Underutredare:
- Alice ILIE, MD
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Underutredare:
- Catherine LEHMANN, MD
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Underutredare:
- Adriana NASTASIE, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Men or women over 18 years·
- Hospitalized for elective surgery and targeted for orotracheal intubation under direct laryngoscopy under general anesthesia with neuromuscular blockade resolved·
- Subject has signed informed consent·
- Suject affiliated to a social protection·
- Subject informed of the results of medical examination
Exclusion Criteria:
- Contraindication to general anesthesia or one of its components·
- General anesthesia without a competitive muscle relaxant·
- Patient with criteria for difficult intubation·
- Patient targeted for special care of the airway (fiberoptic or vidéolaryngoscopy), whatever the indication as Mallampati class 4·
- Subject in class 4 Mallampati·
- Acts performed in the emergency setting·
- Pregnancy and obstetric procedures·
- Breastfeeding·
- Difficulty in communication with the patient (including obtaining informed consent, evaluation of pain in the recovery Room ·
- Subject in exclusion period (determined by a previous study or a study in progress)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Group SU (Single use or Laryngobloc ®) ®)
In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Laryngobloc ®.
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Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®. Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R. |
|
Övrig: Group R (Reusable handle)
In order to avoid an order effect, the patient acting as his own control, will randomly undergo a laryngoscopy with each laryngoscopes, the intubation being performed during the second laryngoscopy, here with the Disposable Metal Blade.
|
Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®. Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The quality of laryngoscopy
Tidsram: 1 year
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The quality of laryngoscopy.
The quality of the visibility of the glottis, is assessed by the Cormack and Lehane grade.
A rank of 1 or 2 will be considered a success for the analysis of results.
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation microbiological and evaluation of intubation
Tidsram: 1 year
|
Evaluation microbiological (bacteria, fungi) and identification of bacteria with smears of the handle of laryngoscopes, the Laryngobloc ® and the reusable battery. Evaluation of intubation: IDS score, satisfaction of the anesthesiologist, intubation time, quality of light offered by the device. |
1 year
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 5131
- 2011-A01548-33 (Annan identifierare: ANSM)
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