Clinical trial NCT05850988: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atelectasis
Keywords: atelectasis
preoxygenation
lung ultrasound
general anesthesia
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ankara Etlik City Hospital
First posted: 2023-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Change of Modified Lung Ultrasound Scores
timeFrame: 3 minutes
Secondary outcomes:
measure: End-Tidal Oxygen levels
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Ozkan D
name: Derya Ozkan, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
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.