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Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine (InSizeS25)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339141
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.

The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position


Condition or disease Intervention/treatment Phase
Intubation Intratracheal Procedure: Intubation position Not Applicable

Detailed Description:

Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).

Interim analysis every 100 patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Placebo Comparator: supine position
Patients are placed in the supine position at 0° from arrival in the room until intubation
Procedure: Intubation position
The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score).

Active Comparator: 25° head-up position
Patients are placed in the 25° head-up position (half-seat or whole body proclive) from arrival in the room until intubation.
Procedure: Intubation position
The investigators assess two different patient's intubation position : supine position and 25° head-up position looking at the intubation score (POGO score).




Primary Outcome Measures :
  1. POGO score [ Time Frame: at day 1 ]
    valid score observed by the anesthetist performing intubation at the time of intubation. POGO score means Percentage of Glottic Opening : from 0% (none visualization of the glottic opening, worst result) to 100% (complete visualization of the glottic opening, best result), from the anterior curvature of the vocal cords to the interarytenoid node, between the posterior cartilage


Secondary Outcome Measures :
  1. Cormack-Lehane grade [ Time Frame: at day 1 ]
    another valid score observed by the anesthetist performing intubation at the time of intubation. It classifies views obtained by direct laryngoscopy based on the structures seen. From 1 (best result) to 4 (worst result). 1 : full view of glottis (POGO 100%) / 2 : partial view of glottis / 3 : only epiglottis seen, none of glottis seen (POGO 0%) / 4 : Neither glottis nor epiglottis seen (POGO 0%).

  2. Intubation operator's comfort [ Time Frame: at day 1 ]
    visual analog scale about the operator's comfort during intubation. It's a subjective score. It's an evaluation of the comfort of the intubation position from 0 to 10, where 0 is a total discomfort, a painful, very uncomfortable position and 10 is an optimal, very comfortable position.

  3. Episodes of desaturation and episodes of hypotension [ Time Frame: at ady 1 ]
    SpO2 <90% or MAP <65mmHg or drop> 20% of the patient's baseline SBP

  4. Mechanical complications of intubation: [ Time Frame: at day 1 ]
    laryngeal pain, hoarseness, upper airway trauma

  5. Patient height [ Time Frame: at day 1 ]
    at the tragus of the ear during intubation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy.
  • > 18 years
  • patients with social security

Exclusion Criteria:

  • Emergency surgery.
  • Patient who requiring rapid sequence induction.
  • Intubation without curare.
  • Expected difficult intubation with planned modification of the intubation protocol (i. e. intubation under fibroscopy, airtrach or videolaryngoscopy)
  • Patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease).
  • Patient with mask phobia.
  • BMI> 30kg / m2
  • Patient who are refusing to take part.
  • Patient protected major, minor, pregnant women, patients deemed incapable of giving informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339141


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 11 95    drci@chu-clermontferrand.fr   
Principal Investigator: Jean-Etienne BAZIN         
Pôle Santé République Recruiting
Clermont-Ferrand, France
Contact: Guillaume GINDRE         
Principal Investigator: Guillaume GINDRE         
Centre Hospitalier Alpes-Léman Recruiting
Contamine-sur-Arve, France
Contact: Claire BIBOULET         
Principal Investigator: Claire BIBOULET         
Polyclinique Saint Odilon Recruiting
Moulins, France, 03000
Contact: Mohamed SOUIB         
Principal Investigator: Mohamed SOUIB         
Sub-Investigator: Fatima Binakdane         
Hôpital Saint-Louis / AP-HP Recruiting
Paris, France
Contact: Lise LACLAUTRE       drci@chu-clermontferrand.fr   
Principal Investigator: Benoit PLAUD         
Hôpital Nord-Ouest Recruiting
Villefranche-sur-Saône, France
Contact: Charlotte FERNANDEZ-CANAL         
Principal Investigator: Charlotte FERNANDEZ-CANAL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Jean-Etienne BAZIN University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03339141    
Other Study ID Numbers: CHU-361
2016-A02078-43 ( Other Identifier: 2016-A02078-43 )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Intubation conditions
Anaesthetic techniques
Laryngoscopy
Additional relevant MeSH terms:
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Disease
Pathologic Processes