Detection of SpO2-oscillations of Low Ventilated Areas

NCT02022969 | Withdrawn DMC

• 1 other identifier: MAS 1120/2013
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis

Keywords

atelectasis; SPO2 - oscillations

Outcome Measures

Primary Outcomes (1)

• Detection of SpO2-oscillations caused by cyclic recruitment and derecruitment of atelectasis.

  Desaturation of SpO2

  20 min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

40 patients in 2 groups

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

MUW/AKH

Vienna, 1090, Austria

Location

Biospecimen

Retention: NONE RETAINED

Spo2 Ventilation

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Klaus Ulrich Klein, PD MD

  MUW/AKH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.-Prof. PD Dr.

Study Record Dates

• First Submitted: December 22, 2013
• First Posted: December 30, 2013
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

AU (1)