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

General Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056807
• Other study ID #: 11506
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: February 14, 2017
• Start date: October 2008
• Est. completion date: August 2011

Study information

• Verified date: February 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• General Surgery

Intervention

Other:
• 25° head-up position
Angle person is positioned for procedure.
• 55° head-up position
Angle person is positioned for procedure.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerable Apneic Time (TAT)	Measure of the TAT between groups to determine if the TAT is a function of the participant's position.	Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes
Secondary	Length of time to intubation (TTI)		Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes
Secondary	Peripheral arterial hemoglobin oxygen saturation (SpO2) trough	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.	Time until SpO2 decreased to 92%, up to 8 minutes