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Completed

NCT Number: NCT05850988

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, 06710, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

%80 Oxygen concentration

Other

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

Other names: %80 Inspired fraction of oxygen

%100 Oxygen concentration

Other

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

Other names: %100 Inspired fraction of oxygen

Primary outcomes

  1. Change of Modified Lung Ultrasound Scores

    Time frame: 3 minutes

    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

Secondary outcomes

  1. End-Tidal Oxygen levels

    Time frame: 3 minutes

    End-tidal oxygen levels at the end of 3 minutes of preoxygenation will be recorded for each participants

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Collaborators

  • Ankara Etlik City Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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