Postoperative Pulmonary AtelectasesNCT02121275
Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period
An observational study of Postoperative Pulmonary Atelectases, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pulmonary Atelectases
- What is being tested?
- Ultrasound of the lungs and Electric impedance tomography
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 6 Sep 2012to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective laparoscopic surgery at the Medical University of Vienna
Who may be able to join
- Male or female,
- age 18 - 75
- BMI < 30
- Laparoscopic operation
Who cannot join
- Pregnancy
- Pulmonary infection
- Chronic pulmonary diseases
- Morbid Obesity
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care
Vienna, A-1090
About this study
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.
- Conditions
- Postoperative Pulmonary Atelectases
- Being tested
- Ultrasound of the lungs, Electric impedance tomography
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the lungsDevice
Also called Sonosite ultrasound device (M-Turbo)
Ultrasound examination of the lungs
Electric impedance tomographyDevice
Also called EIT (Pulmovista, Draeger)
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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | Patients undergoing laparoscopic surgery under general anaesthesia, patients undergo ultrasound of the lungs and electric impedance tomography at 4 times during anaesthesia Receives: Device: Ultrasound of the lungs; Device: Electric impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between evidence of atelectasis in lung ultrasound and evidence of atelectasis in electric impedance tomography
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)
Measured: on the day of laparoscopic surgery, expected average 2 hours in total
Secondary outcomes (1)
respiratory variability of oxygen saturation
from induction of anaesthesia until extubation
Measured: on the day of laparoscopic surgery, expected average 2 hours in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start6 Sep 2012
- Primary completion30 Jun 2016
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary AtelectasesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Roman Ullrich, Medical University of Vienna
- Investigators
- Roman Ullrich, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121275
- Sponsor's protocol ID
- LUS
- Status last verified
- Dec 2022
- First submitted
- 2 Apr 2014
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period
- ClinicalTrials.gov ID
- NCT02121275
- Acronym / sponsor ID
- LUS
- Conditions
- Postoperative Pulmonary Atelectases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Sep 2012 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | – | Device: Ultrasound of the lungs, Device: Electric impedance tomographyPatients undergoing laparoscopic surgery under general anaesthesia, patients undergo ultrasound of the lungs and electric impedance tomography at 4 times during anaesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective laparoscopic surgery at the Medical University of Vienna
Key inclusion criteria (4 listed)
- Male or female,
- age 18 - 75
- BMI < 30
- Laparoscopic operation
Key exclusion criteria (4 listed)
- Pregnancy
- Pulmonary infection
- Chronic pulmonary diseases
- Morbid Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound of the lungsAlso: Sonosite ultrasound device (M-Turbo)Ultrasound examination of the lungs | Device | Laparoscopic surgery |
| Electric impedance tomographyAlso: EIT (Pulmovista, Draeger)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. | Device | Laparoscopic surgery |
Primary outcome
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)
1 secondary outcome
respiratory variability of oxygen saturation
Time frame: on the day of laparoscopic surgery, expected average 2 hours in total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Ullrich, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pulmonary Atelectases, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.