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

Pulmonary Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850988
• Other study ID #: AESH-EK1-2023-001
• Status: Completed
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Atelectasis

Intervention

Other:
• %80 Oxygen concentration
Patients will be administered %80 Oxygen for 3 minutes during preoxygenation.
• %100 Oxygen concentration
Patients will be administered %100 Oxygen for 3 minutes during preoxygenation.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital	Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End-Tidal Oxygen levels	End-tidal oxygen levels at the end of 3 minutes of preoxygenation will be recorded for each participants	3 minutes