COMPLETED

Impact of High Versus Lower Oxygen Fraction Prior to Extubation on Postoperative Pulmonary Atelectasis Measured With EIT

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients undergoing general anesthesia require mechanical ventilation (artificial delivery of air and oxygen to their lungs). It is well known that during mechanical ventilation, so-called atelectasis formation occurs. This is a condition characterized by partial or complete collapse of lung tissue that can result in a reduction in oxygen uptake through the lung. A known risk factor for atelectasis formation during mechanical ventilation is the utilization of high oxygen concentration, as the oxygen molecules are absorbed in the lung, which then can lead to collapse of the tissue. Despite the proven association, standard operating procedure at the end of anesthesia still requires utilization of 100% oxygen. Its justification is the goal to ensure sufficient oxygenation throughout the extubation phase. However, clinical observation doesn't show a lack of oxygenation in this phase, but the patient is still exposed to the risk of atelectasis formation. This study aims to investigate the hypothesis of whether the utilization of reduced inspiratory oxygen concentration before extubation (70% or 40% compared to 100%) reduces atelectasis formation. The study was originally planned to randomize 24 patients to either 70% or 100% inspiratory oxygen concentration at the end of anaesthesia. After completion of this first phase, the study was amended to enroll another 24 patients randomized to 40% or 100% inspiratory oxygen concentration at the end of anaesthesia. Of note, both concentrations are still higher than when breathing room air in, which has of 21% oxygen. During the intervention, parameters such as the oxygen content in the blood (oxygen saturation, SpO₂), heart rate, and blood pressure are recorded, and atelectasis formation is measured using a technique called electrical impedance tomography (EIT). EIT measurements are performed at designated time points during the procedure. Anesthesia care providers are asked to document procedural, patient, and ventilator data in a questionnaire. Secondary outcomes are the homogeneity and distribution of air measured with EIT, as well as some clinical outcomes including post-extubation desaturation (\<90% SpO₂), incidence of re-intubation or non-invasive ventilation, and the Post-anesthesia Care Unit (PACU) length of stay.

Official Title

A Randomized Trial Investigating the Impact of High Versus Lower Oxygen Fraction During Extubation on Postoperative Pulmonary Atelectasis Measured With Electrical Impedance Tomography

Quick Facts

Study Start:2024-09-27
Study Completion:2025-05-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06538740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Elective surgery with general anesthesia and endotracheal intubation
  3. * Expected duration of surgery 1-5 hours
  4. * Consent obtained from patient
  1. * Patients with inability to give written informed consent
  2. * American Society of Anesthesiologists (ASA) physical status\> IV
  3. * Morbid obesity BMI \> 40
  4. * Suspected pregnancy and lactation
  5. * Cardiac or thoracic surgery
  6. * Patients with thoracic epidural catheters
  7. * Patients with active implantable devices, such as pacemakers, cardioverter defibrillators, or neurostimulators
  8. * Compromised airways
  9. * Impaired oxygenation at baseline or during surgery

Contacts and Locations

Study Locations (Sites)

Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-27
Study Completion Date2025-05-22

Study Record Updates

Study Start Date2024-09-27
Study Completion Date2025-05-22

Terms related to this study

Keywords Provided by Researchers

  • Pulmonary Atelectasis [C08.381.730]
  • Oxygen [D01.268.185.550, D01.362.670]
  • Electrical impedance tomography
  • Center of Ventilation
  • lung aeration
  • anesthesia

Additional Relevant MeSH Terms

  • Atelectasis