O2 Versus CPAP Treatment of Patients Undergoing SIPE Therapy (OCTOPUS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxygen + continuous positive airway pressure (CPAP), Oxygen.
- Who it may be relevant to
- Registry conditions: Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Continous Positive Airway Pressure (CPAP) in Swimming Induced Pulmonary Edema (SIPE) -a Randomized Single-blinded Controlled Study
Overview
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.
Detailed description
Swimming induced pulmonary edema (SIPE) is an unusual condition affecting otherwise healthy swimmers. SIPE is characterized by acute onset of dyspnea and cough, excessive sputum and occasionally hemoptysis when swimming in open water. The condition usually resolves spontaneously within 48 hours, but may result in serious illness and require emergency care. Case reports describe acute treatment with oxygen alone or in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (CPAP). Evidence for optimal treatment strategy is lacking. This study intends to determine whether oxygen alone or applied together with CPAP leads to improvement of oxygen saturation and recovery of patients. The aim is to treat patients on site without involving hospital care. We study a large cohort of approximately 12 000 swimmers during Vansbrosimningen, Sweden's biggest annual open water event with a yearly incidence of SIPE about 0,4%.
Adult patients clinically diagnosed with SIPE are randomly assigned in 2 groups receiving treatment during 20 minutes: (1) oxygen 10l/min or (2) oxygen 10l/min and CPAP 7,5 cm H2O. Assessment with outcome measures is taken 10 minutes after treatment. Primary endpoint: oxygen saturation (%) by pulse oxymetry.
Interventions
- Combination product Oxygen + continuous positive airway pressure (CPAP)
Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment - Drug Oxygen
Oxygen: 20 min treatment followed by 10 min rest and assessment
Primary outcome measures
- Absolute peripheral oxygen saturation (%) after treatment [Time frame: after 20 min treatment followed by 10 min rest]
Secondary outcome measures (9)
- Change in absolute peripheral oxygen saturation (%) before and after treatment [Time frame: change before versus after 20 min treatment followed by 10 min rest]
- Recovery (yes/no) after treatment [Time frame: after 20 min treatment followed by 10 min rest]
- Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment [Time frame: after 20 min treatment followed by 10 min rest]
- Absolute number of regions presenting B-lines on lung ultrasound after treatment [Time frame: 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 [Time frame: change before versus after 20 min treatment followed by 10 min rest]
- Change in patient reported outcome measures before and after treatment [Time frame: change before versus after 20 min treatment followed by 10 min rest]
- Admission to hospital (yes/no) [Time frame: 2 hours]
- total treatment time [Time frame: 2 hours]
- subgroup analysis [Time frame: 1 hour]
Eligibility criteria
Inclusion criteria
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤91%)
- 18 years and older
- informed consent
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Center of Clinical Research Dalarna — Falun
Identifiers
NCT: NCT04307615 · OCTOPUS001