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

Sponsor

Diskapi Teaching and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05850988

Collaborator

Ankara Etlik City Hospital (Other)

Enrollment

Location

Arms

1.5

Anticipated Duration (Months)

33.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Atelectasis	Other: %80 Oxygen concentration Other: %100 Oxygen concentration	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change of Modified Lung Ultrasound Scores [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Etlik City Hospital	Ankara		Turkey	06710

Sponsors and Collaborators

Diskapi Teaching and Research Hospital
Ankara Etlik City Hospital

Investigators

Principal Investigator: Derya Ozkan, Professor MD, Ozkan D

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

derya özkan, Professor M.D., Diskapi Teaching and Research Hospital

ClinicalTrials.gov Identifier:

NCT05850988

Other Study ID Numbers:

AESH-EK1-2023-001

First Posted:

May 9, 2023

Last Update Posted:

May 9, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by derya özkan, Professor M.D., Diskapi Teaching and Research Hospital

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of May 9, 2023