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

NCT05850988 | Completed

• 1 other identifier: AESH-EK1-2023-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Atelectasis

Keywords

atelectasis; preoxygenation; lung ultrasound; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• End-Tidal Oxygen levels

  3 minutes

Study Arms (2)

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

%80 Oxygen concentration OTHER

Patients will be administered %80 Oxygen for 3 minutes during preoxygenation.

Also known as: %80 Inspired fraction of oxygen

Group Eighty

%100 Oxygen concentration OTHER

Patients will be administered %100 Oxygen for 3 minutes during preoxygenation.

Also known as: %100 Inspired fraction of oxygen

Group Hundred

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead
• Ankara Etlik City Hospital: collaborator

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06710, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 27669555 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Derya Ozkan, Professor MD

  Ozkan D

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor M.D.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 9, 2023
• Study Start: April 15, 2023
• Primary Completion: May 20, 2023
• Study Completion: June 1, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)