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Completed

NCT Number: NCT03056807

Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia

The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia.

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Key information

Conditions

General Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status II-III patients
  • Body Mass Index (BMI) of 40-60
  • Scheduled for an elective laparoscopic adjustable gastric band surgery

Exclusion criteria

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

Treatment and study plan

25° head-up position

Other

Angle person is positioned for procedure.

55° head-up position

Other

Angle person is positioned for procedure.

Primary outcomes

  1. Tolerable Apneic 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2017
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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