NCT03056820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

January 27, 2017

Last Update Submit

February 14, 2017

Conditions

General Surgery

Keywords

tracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Tolerable Apnea 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 Outcomes (2)

  • 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

Study Arms (2)

A - 25° head-up position

ACTIVE COMPARATOR

Participants will be positioned at 25° angle for procedure.

Other: 25° head-up position

B - 55° head-up position

ACTIVE COMPARATOR

Participants will be positioned at 55° angle for procedure.

Other: 55° head-up position

Interventions

25° head-up positionOTHER

Participant will be positioned at 25° angle for procedure.

A - 25° head-up position
55° head-up positionOTHER

Participant will be positioned at 55° angle for procedure.

B - 55° head-up position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

  • Mirsad Dupanović, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person measuring and recording the study data will be blinded.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 17, 2017

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

US(1)