- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02121275
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
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-
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Vienna, Austria, A-1090
- Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care
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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
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Ultrasound examination of the lungs
Other Names:
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:
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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
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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)
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on the day of laparoscopic surgery, expected average 2 hours in total
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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
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from induction of anaesthesia until extubation
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on the day of laparoscopic surgery, expected average 2 hours in total
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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