Is Effective Preoxygenation in Elderly Patients Related to Position?

July 19, 2023 updated by: Namik ozcan, Ankara City Hospital Bilkent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized into 3 groups. The patients will lay in the supine position, in the control group and 20 and 30 degrees head up position in other two groups. Each patient will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground plane) with the ground will be measured with a spirit level, angle meter, and confirmed with a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients will be measured and recorded with a stopwatch. When the target is reached, anesthesia induction will be performed and the patients will be intubated. After the start of the intubation attempt, the stopwatch will be started again, after intubation, the patient will be ventilated with a balloon once and the location of the tube will be confirmed, the circuit will be separated and SpO2 will be expected to go down to the level of 92 % and recorded during this time.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 91 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age above 65 years
  • ASA 1-2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control
patients will be preoxygenated in supine position
Procedure: Head up positioning during preoxygenation
patients will be preoxygenated in head up position
Experimental: 20 degree
patients will be preoxygenated in 20 degrees head up position
Procedure: Head up positioning during preoxygenation
patients will be preoxygenated in head up position
Experimental: 30 degree
patients will be preoxygenated in 30 degrees head up position
Procedure: Head up positioning during preoxygenation
patients will be preoxygenated in head up position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time ETO2 85%
Time Frame: Time between placement of face mask and end tidal oxygen concentration reaches 85 %
Time to reach ETO2 85 %
Time between placement of face mask and end tidal oxygen concentration reaches 85 %

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation time
Time Frame: Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter
Time to reach the Spo2 of 92 % after intubation
Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

July 19, 2023

Study Completion (Actual)

July 19, 2023

Study Registration Dates

First Submitted

December 11, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E1-22-2775

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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