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Orotracheal Intubation in Adult Patients: A Comparison of Standard Airtraq , Nasotracheal Airtraq Combined With a Stylet Inserted Endotracheal Tube and Standard Airtraq Combined Fiberoptic Intubation

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ClinicalTrials.gov Identifier: NCT03709524
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Zehra Ipek ARSLAN, Kocaeli University

Brief Summary:
Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq, Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination groups.

Condition or disease Intervention/treatment Phase
Difficult Intubation Device: Airtraq + fiberoptic Device: Airtraq Device: Nasotracheal Airtraq + styletted tube Not Applicable

Detailed Description:
We enroll lean adult patients requiring endotracheal intubation. Using a sealed envelope technique they divided into three groups; Standard Airtraq and Nasotracheal Airtraq + styletted endotracheal tube and Standard Airtraq + fiberoptic combination. Demographic characteristics and airway management variables such; age, gender, height, weight, ASA status, tooth morphology, tiro mental and sternomental distance were recorded. Insertion times, intubation times and total intubation times with these devices will be recorded. Hemodynamic parameters recorded such as; heart rate will be recorded baseline , after anesthesia, after insertion, just after and then every 2 minutes intervals after intubation. sore throat, hoarseness, dysphasia, bronchospasm were also recorded postoperatively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Comparison of Airtraq and Nasotracheal Airtraq for Orotracheal Intubation
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : February 20, 2019
Actual Study Completion Date : February 20, 2019

Arm Intervention/treatment
Active Comparator: insertion time
1 minute Airtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic
Device: Airtraq + fiberoptic
video laryngoscope with a monitor
Other Name: videolaryngoscope

Device: Airtraq
video laryngoscope with a monitor
Other Name: videolaryngoscope

Device: Nasotracheal Airtraq + styletted tube
video laryngoscope with a monitor
Other Name: videolaryngoscope

Active Comparator: intubation time
2 minutesAirtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic
Device: Airtraq + fiberoptic
video laryngoscope with a monitor
Other Name: videolaryngoscope

Device: Airtraq
video laryngoscope with a monitor
Other Name: videolaryngoscope

Device: Nasotracheal Airtraq + styletted tube
video laryngoscope with a monitor
Other Name: videolaryngoscope




Primary Outcome Measures :
  1. Intubation time [ Time Frame: 6 months ]
    entering the oral cavity till intubation


Secondary Outcome Measures :
  1. insertion time [ Time Frame: 6 months ]
    entering the oral cavity till the optimal visualization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI<30
  • > 18 AGE
  • requiring endotracheal intubation
  • ASA 1-2

Exclusion Criteria:

  • BMI> 30
  • < 18 AGE
  • ASA III-IV
  • upper respiratory infection past ten days
  • pregnant

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): NCT03709524


Locations
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Turkey
Kocaeli University Medical Faculty
Kocaeli, Turkey
Sponsors and Collaborators
Kocaeli University

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Responsible Party: Zehra Ipek ARSLAN, Associate Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT03709524    
Other Study ID Numbers: KIA 2018/446
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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