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Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation (DISPOSITIF LAR)

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ClinicalTrials.gov Identifier: NCT03614598
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief Summary:
The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%

Condition or disease Intervention/treatment Phase
Pharyngolaryngeal Postoperative Pain Procedure: Insertion of LMA-UNIQUE(TM) device Procedure: Insertion of LMA-SUPREME(TM) device Procedure: Insertion of I-GEL(R) device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation
Actual Study Start Date : April 22, 2009
Actual Primary Completion Date : September 5, 2012
Actual Study Completion Date : September 5, 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LMA-UNIQUE™ Procedure: Insertion of LMA-UNIQUE(TM) device
LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
Active Comparator: LMA-SUPREME™ Procedure: Insertion of LMA-SUPREME(TM) device
LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
Active Comparator: I-GEL® Procedure: Insertion of I-GEL(R) device
I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of pharyngolaryngeal postoperative pain of the three devices [ Time Frame: 24 hours ]
    Sore throat Y/N


Secondary Outcome Measures :
  1. Pharyngolaryngeal postoperative pain between groups [ Time Frame: 2 hours ]
    Sore throat Y/N

  2. Time taken to place device [ Time Frame: End of surgery (maximum 2 hours) ]
    From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds)

  3. Number of attempts needed to place device [ Time Frame: End of surgery (maximum 2 hours) ]
  4. Necessity of altering the size of the device [ Time Frame: End of surgery (maximum 2 hours) ]
    Y/N

  5. Any patient movement during procedure [ Time Frame: End of surgery (maximum 2 hours) ]
    Y/N

  6. Difficulty of insertion [ Time Frame: End of surgery (maximum 2 hours) ]
    5-point scale: very easy-failure

  7. Total leakage pressure of the devices [ Time Frame: End of surgery (maximum 2 hours) ]
    measured directly by the respirator

  8. Ventilatory pressure of the devices [ Time Frame: End of surgery (maximum 2 hours) ]
  9. Device stability during surgery [ Time Frame: End of surgery (maximum 2 hours) ]
    Need to change the management system airways (orotracheal intubation or others) Y/N

  10. Difficulty of device removal [ Time Frame: End of surgery (maximum 2 hours) ]
    4-point scale: very easy-very difficult


Eligibility Criteria
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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:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • Adult patients > 18
  • ASA score I-III
  • Patient scheduled to undergo elective surgery lasting less than two hours under general anaesthetic without tracheal intubation
  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • Emergency surgery
  • Sore thoat ≤ 1 month
  • Risk of aspiration of gastric contents
  • Body mass index (BMI) > 35
  • Patients with expected airway difficulties
  • Contra-indication for any of the devices (symptomatic hiatal hernias, pathological obesity, poly trauma or serious injury, delayed gastric emptying, use of opiates during fasting)
  • Patients who are not fasting for routine and emergency anesthesia
  • Trismus, limited mouth opening, abscess or pharyngoperilaryngeal mass
Contacts and Locations
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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): NCT03614598


Locations
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France
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Joël L'Hermite, MD CHU Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03614598    
Other Study ID Numbers: Local/2008/JL- 02
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations