NCT05659758

Brief Summary

The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

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

August 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

December 11, 2022

Last Update Submit

July 19, 2023

Conditions

Anesthesia Intubation Complication

Keywords

preoxygenation, elderly

Outcome Measures

Primary Outcomes (1)

  • Time ETO2 85%

    Time to reach ETO2 85 %

    Time between placement of face mask and end tidal oxygen concentration reaches 85 %

Secondary Outcomes (1)

  • Desaturation time

    Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter

Study Arms (3)

control

OTHER

patients will be preoxygenated in supine position

Procedure: Head up positioning during preoxygenation

20 degree

EXPERIMENTAL

patients will be preoxygenated in 20 degrees head up position

Procedure: Head up positioning during preoxygenation

30 degree

EXPERIMENTAL

patients will be preoxygenated in 30 degrees head up position

Procedure: Head up positioning during preoxygenation

Interventions

Head up positioning during preoxygenationPROCEDURE

patients will be preoxygenated in head up position

20 degree30 degreecontrol

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age above 65 years
  • ASA 1-2

You may not qualify if:

  • heart failure
  • uncooperative
  • patients refusing well fitting face mask before reaching EtO2 85%
  • chronic lung disease
  • anemia (hb\<8gr/dl)
  • BMI\>40
  • neurological sequela

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Reanimation, Principle Investigator

Study Record Dates

First Submitted

December 11, 2022

First Posted

December 21, 2022

Study Start

August 1, 2022

Primary Completion

July 19, 2023

Study Completion

July 19, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

TU(1)