Effects of Different Oxygen Concentrations on Lung Ultrasound Score During Spontaneous Ventilation

December 8, 2023 updated by: derya özkan, Diskapi Teaching and Research Hospital

Effects of Different Oxygen Concentrations for Preoxygenation on Lung Ultrasound Scores During Spontaneous Ventilation

The goal of this study is to observe the effects of different oxygen concentrations during preoxygenation in spontaneous breathing patients with modified lung ultrasound scores before induction of general anesthesia. Preoxygenation is a routine and recommended procedure for patients undergoing general anesthesia. Atelectasis is a common side effect of general anesthesia and usage of high concentration oxygen is a probable cause of it. Using lower oxygen concentrations in preoxygenation may help reducing the atelectasis and it can be assessed by lung ultrasound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preoxygenation is the process of supplying the patient a high inspired fraction of oxygen prior to an airway intervention or induction of general anesthesia. Prolonging safe apnea duration is the primary aim of preoxygenation and preoxygenation is recommended for all patients before induction of general anesthesia.

Atelectasis is the most common postoperative pulmonary complication and is associated with usage of high inspired fraction of oxygen. Modified lung ultrasound scoring is an effective and noninvasive method to determine atelectasis. In this study we will observe the effects of different oxygen concentrations during preoxygenation before induction of general anesthesia in spontaneous breathing patients with modified lung ultrasound scores .

Patients undergoing general anesthesia for elective surgery meeting the criteria will be acknowledged about the study. After written consents are taken patients will be randomised into two groups by coin method. One group will receive %80 oxygen for 3 minutes and other group will receive %100 oxygen for 3 minutes during preoxygenation. Each participants demographic data will be collected. 12 quadrants of thorax divided by midsternal line, anterior axillary and posterior axillary lines will be examined by the usage of modified lung ultrasound score before and at the end of preoxygenation for all individuals. Randomisation, lung ultrasound scoring and preoxygenation will be done by different experienced anesthesiologists so the observers of this study would be blinded for the results. Patients will be blinded for the concentration of oxygen. Modified lung scores of each group would be compared at the end of the study.

Study Type

Interventional

Enrollment (Actual)

50

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 Contact

  • Name: Derya Ozkan, Professor MD
  • Phone Number: +90 542 584 36 38
  • Email: derya_z@yahoo.com

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06710
        • Ankara Etlik 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • American Society of Anesthesiologists Score I and II
  • Being a candidate to elective surgery under general anesthesia

Exclusion Criteria:

  • Patients with any pulmonary disease
  • Patients who had pulmonary infection in the past 3 months
  • Patients who had a surgery in the past 3 months
  • Patients who had a multitrauma in the past 3 months
  • Patients who have a Body Mass Index over 30
  • Pregnants
  • Patients who have diaphragma hernia
  • Patients who have gastroesophageal reflux disease

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Eighty
Patients in Group E will receive %80 oxygen for 3 minutes during preoxygenation
Other: %80 Oxygen concentration
Patients will be administered %80 Oxygen for 3 minutes during preoxygenation.
Other Names:
  • %80 Inspired fraction of oxygen
Active Comparator: Group Hundred
Patients in Group H will receive %100 oxygen for 3 minutes during preoxygenation
Other: %100 Oxygen concentration
Patients will be administered %100 Oxygen for 3 minutes during preoxygenation.
Other Names:
  • %100 Inspired fraction of oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Modified Lung Ultrasound Scores
Time Frame: 3 minutes
Scores between 0-3 for 12 thorax quadrants and total score will be recorded for each participants before and after a 3 minutes time of preoxygenation to assess change from baseline
3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-Tidal Oxygen levels
Time Frame: 3 minutes
End-tidal oxygen levels at the end of 3 minutes of preoxygenation will be recorded for each participants
3 minutes

Collaborators and Investigators

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

Sponsor

Diskapi Teaching and Research Hospital

Collaborators

Ankara Etlik City Hospital

Investigators

  • Principal Investigator: Derya Ozkan, Professor MD, Ozkan D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2023

Primary Completion (Actual)

May 20, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AESH-EK1-2023-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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