search
Back to results

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

Primary Purpose

Pulmonary Atelectasis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
%80 Oxygen concentration
%100 Oxygen concentration
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pulmonary Atelectasis focused on measuring atelectasis, preoxygenation, lung ultrasound, general anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara Etlik City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Eighty

Group Hundred

Arm Description

Patients in Group E will receive %80 oxygen for 3 minutes during preoxygenation

Patients in Group H will receive %100 oxygen for 3 minutes during preoxygenation

Outcomes

Primary Outcome Measures

Change of Modified Lung Ultrasound Scores
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

Secondary Outcome Measures

End-Tidal Oxygen levels
End-tidal oxygen levels at the end of 3 minutes of preoxygenation will be recorded for each participants

Full Information

First Posted
April 6, 2023
Last Updated
May 29, 2023
Sponsor
Diskapi Teaching and Research Hospital
Collaborators
Ankara Etlik City Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05850988
Brief Title
Effects of Different Oxygen Concentrations on Lung Ultrasound Score During Spontaneous Ventilation
Official Title
Effects of Different Oxygen Concentrations for Preoxygenation on Lung Ultrasound Scores During Spontaneous Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
Collaborators
Ankara Etlik City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
atelectasis, preoxygenation, lung ultrasound, general anesthesia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Eighty
Arm Type
Active Comparator
Arm Description
Patients in Group E will receive %80 oxygen for 3 minutes during preoxygenation
Arm Title
Group Hundred
Arm Type
Active Comparator
Arm Description
Patients in Group H will receive %100 oxygen for 3 minutes during preoxygenation
Intervention Type
Other
Intervention Name(s)
%80 Oxygen concentration
Other Intervention Name(s)
%80 Inspired fraction of oxygen
Intervention Description
Patients will be administered %80 Oxygen for 3 minutes during preoxygenation.
Intervention Type
Other
Intervention Name(s)
%100 Oxygen concentration
Other Intervention Name(s)
%100 Inspired fraction of oxygen
Intervention Description
Patients will be administered %100 Oxygen for 3 minutes during preoxygenation.
Primary Outcome Measure Information:
Title
Change of Modified Lung Ultrasound Scores
Description
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
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
End-Tidal Oxygen levels
Description
End-tidal oxygen levels at the end of 3 minutes of preoxygenation will be recorded for each participants
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Derya Ozkan, Professor MD
Phone
+90 542 584 36 38
Email
derya_z@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aras Metin, MD
Phone
+90 554 890 00 66
Email
drarasmetin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Ozkan, Professor MD
Organizational Affiliation
Ozkan D
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Etlik City Hospital
City
Ankara
ZIP/Postal Code
06710
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derya Ozkan, Professor MD
Phone
+90 542 584 36 38
Email
derya_z@yahoo.com
First Name & Middle Initial & Last Name & Degree
Aras Metin, MD
Phone
+90 554 80 00 66
Email
drarasmetin@gmail.com
First Name & Middle Initial & Last Name & Degree
Aras Metin, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27669555
Citation
Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs