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Comparison of Apnea Tolerance in Two Positions of Patients With BMI 30-40

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ClinicalTrials.gov Identifier: NCT03056820
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apnea time (TAT) after induction of general anesthesia in patients with a body mass index (BMI) of 30-40.

Condition or disease Intervention/treatment Phase
General Surgery Other: 25° head-up position Other: 55° head-up position Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The person measuring and recording the study data will be blinded.
Primary Purpose: Health Services Research
Official Title: Comparison of Apnea Tolerance in Two Positions of Patients With Body Mass Index (BMI) 30-40
Actual Study Start Date : May 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Active Comparator: A - 25° head-up position
Participants will be positioned at 25° angle for procedure.
Other: 25° head-up position
Participant will be positioned at 25° angle for procedure.

Active Comparator: B - 55° head-up position
Participants will be positioned at 55° angle for procedure.
Other: 55° head-up position
Participant will be positioned at 55° angle for procedure.




Primary Outcome Measures :
  1. Tolerable Apnea Time (TAT) [ Time Frame: Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes ]
    Measure of the TAT between groups to determine if the TAT is a function of the participant's position.


Secondary Outcome Measures :
  1. Length of time to intubation (TTI) [ Time Frame: Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes ]
  2. Peripheral arterial hemoglobin oxygen saturation (SpO2) trough [ Time Frame: Time until SpO2 decreased to 92%, up to 8 minutes ]
    Measure of the rebound SpO2. It is the lowest SpO2 reading reached subsequent to start of mechanical ventilation at the SpO2 value of 94% and it represents final completion of SpO2 decline.



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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:

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body Mass Index (BMI) of 30-40
  • Scheduled for an elective surgery that requires tracheal intubation

Exclusion Criteria:

  • Patients with abnormalities of the upper airway that require awake tracheal intubation
  • Asthma
  • Chronic obstructive pulmonary disease
  • Congestive heart failure
  • Pregnant patients

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): NCT03056820


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Mirsad Dupanović, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03056820     History of Changes
Other Study ID Numbers: 12197
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
tracheal intubation