AtelectasisMASNCT02022969
Detection of SpO2-oscillations of Low Ventilated Areas
An observational study of Atelectasis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Even though experimental lung injury in animal experiments is the best analogy for the changes in the patients, it has to be considered that kinetics may vary between species. An important question to answer is how common PaO2-oscillations occur in patients and how injurious they might be. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2024to 31 Dec 2024
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 patients in 2 groups
Who may be able to join
- Interventional group:
- Patients who are at high risk of developing atelectasis at the end of the operation, i.e. having had large abdominal surgery for longer than 4 hours.
- Control group:
- Patients who are at low risk of developing atelectasis at the end of the operation, i.e. having had neurosurgical treatment without opening the abdomen
Who cannot join
- Interventional + control group:
- Age < 18yr, alcohol or drug abuse, pregnancy, participation in another study, skin lesions on the fingers, allergy to patches or other severe allergies, patients who cannot give their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of SpO2-oscillations Caused by Cyclic Recruitment and Derecruitment of Low Ventilated Areas in the Lung (Atelectasis) During Mechanical Ventilation
Even though experimental lung injury in animal experiments is the best analogy for the changes in the patients, it has to be considered that kinetics may vary between species. An important question to answer is how common PaO2-oscillations occur in patients and how injurious they might be. A limitation to the detection of PaO2-oscillations is a sensing device that detects the oscillations at very high temporal resolution. In previous studies a fiberoptic probe was used, which was measuring PaO2 based on oxygen-sensitive fluorescence quenching with a time resolution up to 10 Hz (8, 13, 14). This method is not feasible in patients. Previous studies have shown that PaO2-oscillations are translated into the peripheral hemoglobin oxygen saturation (SpO2). Given a technology that has a time resolution that is high enough (i.e. >1 Hz), measurement of SpO2-oscillations would be a valid approach to detecting and quantifying cyclical recruitment and derecruitment in a non-invasive fashion in patients on the ICU. The Masimo Rad-8 pulse-oxymeter provides such a method. In the current study it is planned to deteted SpO2-oscillations in the post-operative patients on the ICU.
Read the detailed description
As stated above cyclical recruitment and derecruitment has been shown a mechanism of VALI. It has further been demonstrated that PaO2-oscillations in the systemic circulation are transmitted to endorgans (i.e. brain, kidney and other peripheral organs). There have no studies quantifying PaO2- or SpO2-oscillations in human subjects. The rationale of this study is to measure non-invasively SpO2-oscillations throughout the respiratory cycle as PaO2 oscillations cannot easily be detected. We will analyse SpO2-oscillations in a cohort of post-operative patients. Atelectasis is a major risk factor for pulmonary complications. As it occurs in up to 90% of surgical patients this phenomenon is highly relevant. Patients with large areas of atelectatic lung tissue are prone to cyclical recruitment and derecruitment and consecutive SpO2-oscillations.
There will be two groups of patients: One with a high risk for atelectasis and one with low risk for atelectasis. The patients are stratified by the type of surgery. Upper abdominal surgery with a duration of more than 2 hours has been shown to be an independent risk factor for atelectasis. Therefore, we chose to assign patients scheduled for abdominal surgery with an anticipated duration of surgery of more than 4 hours for the high-risk group. Patients with neurosurgical procedures with more than 4 hours will be assigned to the low risk group. In each patient the SpO2-oscillations will be measured at three different respiratory rates (RR). The rationale for this is that previous studies showed that cyclical recruitment and derecruitment is dependent on the RR.
- Conditions
- Atelectasis
- Keywords
- atelectasis, SPO2 - oscillations
- Medical subject headings
- Pulmonary Atelectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SpO2-oscillations caused by cyclic recruitment and derecruitment of atelectasis.
Desaturation of SpO2
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Personell
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ass.-Prof. PD Dr. Klaus Ulrich Klein, Medical University of Vienna
- Investigators
- Klaus Ulrich Klein, PD MD, Principal investigator, MUW/AKH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022969
- Sponsor's protocol ID
- MAS 1120/2013
- Acronym
- MAS
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2013
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of SpO2-oscillations Caused by Cyclic Recruitment and Derecruitment of Low Ventilated Areas in the Lung (Atelectasis) During Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02022969
- Acronym / sponsor ID
- MAS / MAS 1120/2013
- Conditions
- Atelectasis
- Keywords
- atelectasis, SPO2 - oscillations
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Personell
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Dec 2013 (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.
Even though experimental lung injury in animal experiments is the best analogy for the changes in the patients, it has to be considered that kinetics may vary between species. An important question to answer is how common PaO2-oscillations occur in patients and how injurious they might be. A limitation to the detection of PaO2-oscillations is a sensing device that detects the oscillations at very high temporal resolution. In previous studies a fiberoptic probe was used, which was measuring PaO2 based on oxygen-sensitive fluorescence quenching with a time resolution up to 10 Hz (8, 13, 14). This method is not feasible in patients. Previous studies have shown that PaO2-oscillations are translated into the peripheral hemoglobin oxygen saturation (SpO2). Given a technology that has a time resolution that is high enough (i.e. >1 Hz), measurement of SpO2-oscillations would be a valid approach to detecting and quantifying cyclical recruitment and derecruitment in a non-invasive fashion in patients on the ICU. The Masimo Rad-8 pulse-oxymeter provides such a method. In the current study it is planned to deteted SpO2-oscillations in the post-operative patients on the ICU.
Detailed description
As stated above cyclical recruitment and derecruitment has been shown a mechanism of VALI. It has further been demonstrated that PaO2-oscillations in the systemic circulation are transmitted to endorgans (i.e. brain, kidney and other peripheral organs). There have no studies quantifying PaO2- or SpO2-oscillations in human subjects. The rationale of this study is to measure non-invasively SpO2-oscillations throughout the respiratory cycle as PaO2 oscillations cannot easily be detected. We will analyse SpO2-oscillations in a cohort of post-operative patients. Atelectasis is a major risk factor for pulmonary complications. As it occurs in up to 90% of surgical patients this phenomenon is highly relevant. Patients with large areas of atelectatic lung tissue are prone to cyclical recruitment and derecruitment and consecutive SpO2-oscillations.
There will be two groups of patients: One with a high risk for atelectasis and one with low risk for atelectasis. The patients are stratified by the type of surgery. Upper abdominal surgery with a duration of more than 2 hours has been shown to be an independent risk factor for atelectasis. Therefore, we chose to assign patients scheduled for abdominal surgery with an anticipated duration of surgery of more than 4 hours for the high-risk group. Patients with neurosurgical procedures with more than 4 hours will be assigned to the low risk group. In each patient the SpO2-oscillations will be measured at three different respiratory rates (RR). The rationale for this is that previous studies showed that cyclical recruitment and derecruitment is dependent on the RR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients in 2 groups
Key inclusion criteria (4 listed)
- Patients who are at high risk of developing atelectasis at the end of the operation, i.e. having had large abdominal surgery for longer than 4 hours.
- Patients who are at low risk of developing atelectasis at the end of the operation, i.e. having had neurosurgical treatment without opening the abdomen
Key exclusion criteria (2 listed)
- Age < 18yr, alcohol or drug abuse, pregnancy, participation in another study, skin lesions on the fingers, allergy to patches or other severe allergies, patients who cannot give their consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of SpO2-oscillations caused by cyclic recruitment and derecruitment of atelectasis.
Time frame: 20 min
Desaturation of SpO2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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.
Klaus Ulrich Klein, PD MD principal investigator
MUW/AKH
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 Atelectasis, 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 2 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: withdrawn, as of the sponsor's last update on 23 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Detection of SpO2-oscillations caused by cyclic recruitment and derecruitment of atelectasis. (time frame: 20 min). 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 23 Mar 2023.