Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period

December 31, 2022 updated by: Dr. Roman Ullrich, Medical University of Vienna
Atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients who are anaesthetized and intubated. The goal of the present prospective study is to detect atelectatic areas in the perioperative period in the lungs of patients undergoing elective laparoscopic surgery non-invasively and without x-ray exposure. Results of lung ultrasound (LUS) as the experimental method will be compared to the results of Electrical Impedance Tomography (EIT) as the reference technique for the detection of atelectasis. A device for peripheral Oxygen saturation measurement (MASIMO Radical-8) will detect changes in ventilation. The investigators want to confirm or disprove former findings of the appearance of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective laparoscopic surgery at the Medical University of Vienna

Description

Inclusion Criteria:

  • Male or female,
  • age 18 - 75
  • BMI < 30
  • Laparoscopic operation

Exclusion Criteria:

  • Pregnancy
  • Pulmonary infection
  • Chronic pulmonary diseases
  • Morbid Obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laparoscopic surgery
Patients undergoing laparoscopic surgery under general anaesthesia, patients undergo ultrasound of the lungs and electric impedance tomography at 4 times during anaesthesia
Device: Ultrasound of the lungs
Ultrasound examination of the lungs
Other Names:
  • Sonosite ultrasound device (M-Turbo)
Device: Electric impedance tomography
Electric impedance tomography (EIT) is a noninvasive tool based on the measurement of electrical impedance changes within the thorax and lung tissue during ventilation and depicts the regional changes in ventilation in real time. To use electric impedance tomography 16 electrodes are applied in a circular fashion around the patient's chest, typically at the level of the 7th intercostal space.
Other Names:
  • EIT (Pulmovista, Draeger)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between evidence of atelectasis in lung ultrasound and evidence of atelectasis in electric impedance tomography
Time Frame: on the day of laparoscopic surgery, expected average 2 hours in total
Measurements, requiring 5 minutes each, are performed before induction of anaesthesia, after intubation, immediately before extubation and immediately after extubation. Outcome measure: comparison of how often atelectases are detected by lung ultrasound (experimental method) versus by electric impedance tomography (standard method)
on the day of laparoscopic surgery, expected average 2 hours in total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory variability of oxygen saturation
Time Frame: on the day of laparoscopic surgery, expected average 2 hours in total
from induction of anaesthesia until extubation
on the day of laparoscopic surgery, expected average 2 hours in total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

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 Major Dates

Study Start (Actual)

September 6, 2012

Primary Completion (Actual)

June 30, 2016

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 31, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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