Detection of SpO2-oscillations of Low Ventilated Areas (MAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02022969
Recruitment Status : Not yet recruiting
First Posted : December 30, 2013
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Ass.-Prof. PD Dr. Klaus Ulrich Klein, Medical University of Vienna

Brief 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. 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.

Condition or disease

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 Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of SpO2-oscillations Caused by Cyclic Recruitment and Derecruitment of Low Ventilated Areas in the Lung (Atelectasis) During Mechanical Ventilation
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Primary Outcome Measures :
  1. Detection of SpO2-oscillations caused by cyclic recruitment and derecruitment of atelectasis. [ Time Frame: 20 min ]
    Desaturation of SpO2

Biospecimen Retention:   None Retained
Spo2 Ventilation

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
40 patients in 2 groups

Inclusion Criteria:

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

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02022969

Contact: Verena Frithum, MD 0043140400 ext 41020
Contact: Klaus U Klein, MD 0043140400 ext 41020

Vienna, Austria, 1090
MUW/AKH Not yet recruiting
Vienna, Austria, 1090
Contact: Verena Kovar, Me   
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Klaus Ulrich Klein, PD MD MUW/AKH

Responsible Party: Ass.-Prof. PD Dr. Klaus Ulrich Klein, Ass.-Prof. PD Dr., Medical University of Vienna Identifier: NCT02022969     History of Changes
Other Study ID Numbers: MAS 1120/2013
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Ass.-Prof. PD Dr. Klaus Ulrich Klein, Medical University of Vienna:
SPO2 - oscillations

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases