Effects of Different Oxygen Concentrations on Lung Ultras... | NCT05850988

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

NCT05850988

Sponsor

Diskapi Teaching and Research Hospital

Status

Completed

Last Update Posted

Dec 11, 2023Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Pulmonary Atelectasis

Interventions

%80 Oxygen concentration
%100 Oxygen concentration

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2023Actual

Primary Completion Date

May 20, 2023Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Apr 6, 2023

First Submission Date that Met QC Criteria

May 5, 2023

First Posted Date

May 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2023

Last Update Posted Date

Dec 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

derya özkan, Professor M.D., Diskapi Teaching and Research HospitalPrincipal Investigator

Lead Sponsor

Diskapi Teaching and Research HospitalOTHER

Collaborators

Name	Class
Ankara Etlik City Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Eighty	Active Comparator	Patients in Group E will receive %80 oxygen for 3 minutes during preoxygenation	Other: %80 Oxygen concentration
Group Hundred	Active Comparator	Patients in Group H will receive %100 oxygen for 3 minutes during preoxygenation	Other: %100 Oxygen concentration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
%80 Oxygen concentration	Other	Patients will be administered %80 Oxygen for 3 minutes during preoxygenation.	Group Eighty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 minutes

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Derya Ozkan, Professor MD	Ozkan D	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Etlik City Hospital		Ankara		06710	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27669555	Background	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.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases