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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03056807

Enrollment

Registered

2017-02-17

Start date

2008-10-31

Completion date

2011-08-31

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Surgery

Keywords

tolerable apneic time, bariatric surgery, gastric band surgery, intubation

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 apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia.

Interventions

OTHER25° head-up position

Angle person is positioned for procedure.

OTHER55° head-up position

Angle person is positioned for procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Masking description

The person measuring and recording the study data (timer) will be blinded.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tolerable Apneic Time (TAT)	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

Measure	Time frame	Description
Length of time to intubation (TTI)	Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes	—
Peripheral arterial hemoglobin oxygen saturation (SpO2) trough	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026