O2 Versus CPAP Treatment of Patients Undergoing SIPE Therapy (OCTOPUS)
OCTOPUS
Evaluation of Continous Positive Airway Pressure (CPAP) in Swimming Induced Pulmonary Edema (SIPE) -a Randomized Single-blinded Controlled Study
1 other identifier
interventional
90
1 country
1
Brief Summary
In swimming induced pulmonary edema (SIPE), there is a lack of knowledge regarding optimal treatment. The present study was designed to assess the benefit of continuous positive airway pressure (CPAP) compared to oxygen as a first line treatment of SIPE in the out-of-hospital environment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
July 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2027
February 27, 2025
February 1, 2025
5 years
February 4, 2020
February 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute peripheral oxygen saturation (%) after treatment
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry
after 20 min treatment followed by 10 min rest
Secondary Outcomes (9)
Change in absolute peripheral oxygen saturation (%) before and after treatment
change before versus after 20 min treatment followed by 10 min rest
Recovery (yes/no) after treatment
after 20 min treatment followed by 10 min rest
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
after 20 min treatment followed by 10 min rest
Absolute number of regions presenting B-lines on lung ultrasound after treatment
after 20 min treatment followed by 10 min rest
Change in absolute number of regions presenting B-lines on lung ultrasound before and after treatment
change before versus after 20 min treatment followed by 10 min rest
- +4 more secondary outcomes
Study Arms (2)
Oxygen + CPAP-treatment
EXPERIMENTALOxygen-treatment
ACTIVE COMPARATORInterventions
Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment
Eligibility Criteria
You may qualify if:
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤91%)
- years and older
- informed consent
You may not qualify if:
- declined consent
- suspected acute coronary syndrome
- severe asthma diagnosed together with pulmonary edema where beta-agonist-inhalation is needed prior to treatment of pulmonary edema
- hemodynamic instability or decreased consciousness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center of Clinical Research Dalarna
Falun, 79182, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine
Study Record Dates
First Submitted
February 4, 2020
First Posted
March 13, 2020
Study Start
July 2, 2022
Primary Completion (Estimated)
July 15, 2027
Study Completion (Estimated)
July 15, 2027
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share