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

NCT ID: NCT05850988

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Pulmonary Atelectasis

Keywords

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atelectasis preoxygenation lung ultrasound general anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Eighty

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

Group Type ACTIVE_COMPARATOR

%80 Oxygen concentration

Intervention Type OTHER

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

Group Hundred

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

Group Type ACTIVE_COMPARATOR

%100 Oxygen concentration

Intervention Type OTHER

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

Interventions

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%80 Oxygen concentration

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

Intervention Type OTHER

%100 Oxygen concentration

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

Intervention Type OTHER

Other Intervention Names

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%80 Inspired fraction of oxygen %100 Inspired fraction of oxygen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role collaborator

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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derya özkan

Professor M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya Ozkan, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Ozkan D

Locations

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Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27669555 (View on PubMed)

Other Identifiers

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AESH-EK1-2023-001

Identifier Type: -

Identifier Source: org_study_id