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Videolaryngoscopy for Intubation in Patients With Diabetes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089528
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

Brief Summary:

The use of videolarygoscopy (VL) as first choice for tracheal intubation versus direct laryngoscopy (DL) is a matter of debate.

These two methods were compared in several studies. Videolaryngoscopes may reduce the number of failed intubations, particularly among patients presenting with a difficult airway. They improve the glottic view and may reduce airway trauma. DM is accepted as a risk factor for difficult intubation.

The aim of this study is to compare VL to DL in adult patients requiring tracheal intubation for anesthesia, in terms of intubation success, glottic view quality, intubation failure, intubation time, conversion to another laringoscopy method and adverse outcomes related to tracheal intubation.


Condition or disease Intervention/treatment Phase
Anesthesia Diabetes Mellitus Intubation;Difficult Videolaryngoscopy Device: Videolaryngoscopy Device: laringoscope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prosspective randomised
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Videolaryngoscopy Versus Direct Laryngoscopy for Tracheal Intubation in Patients With Diabetes Mellitus
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : November 25, 2018
Actual Study Completion Date : November 25, 2018

Arm Intervention/treatment
Experimental: Videolaryngoscopy
the trachea will be intubated using a videolaringoscope
Device: Videolaryngoscopy
the trachea will be intubated with a videolaryngoscope

Active Comparator: Direct laringoscopy
the trachea will be intubated using a laringoscope
Device: laringoscope
the trachea will be intubated with a laringoscope




Primary Outcome Measures :
  1. first-attempt intubation success rate [ Time Frame: first second after intubation ]
    successful intubation with the allocated device

  2. intubation time [ Time Frame: 0-120 seconds after intubation ]
    The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2

  3. intubation difficulty [ Time Frame: 0-12 seconds after intubation ]
    number of attempts, number of operators, number of alternative techniques, CL grade, lifting force, laryngeal pressure, position of the vocal cords,


Secondary Outcome Measures :
  1. glottic view quality [ Time Frame: during laringoscopy ]
    Cormack Lehane

  2. percentage of glottic opening [ Time Frame: during laringoscopy ]
    the percentage of glottic opening seen, defined by the linear span from the anterior commisure to the interarytenoid notch

  3. the rate of conversion to another laryngoscopy method [ Time Frame: 5 seconds after the first attempt to intubate ]
    the intubation device will be changed if the anestshetist fails to intubate with the allocated device

  4. adverse outcomes related to tracheal intubation. [ Time Frame: 1 minute after intubation ]
    Hypertension, tachycardia, desaturation, hypercarbia, airway trauma, laryngospasm, bronchospasm, sore throat,



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective surgery
  • Patients needing endotracheal intubation
  • Patients having diabetes mellitus

Exclusion Criteria:

  • Emergency surgery

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): NCT03089528


Locations
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Turkey
University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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Principal Investigator: Dilek Yazicioglu, Assoc Prof Netherlands: Ministry of Health, Welfare and Sports
Publications:
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Responsible Party: DILEK YAZICIOGLU, Associate Proffesor, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT03089528    
Other Study ID Numbers: Dilek Ünal
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital:
Direct laryngoscopy
Videolaryngoscopy
Diabetes Mellitus
Intubation
Anesthesia
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases