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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Pulmonary Edema; Swimming Induced Pulmonary Edema (SIPE)
• Intervention / Treatment: Combination product: Oxygen + continuous positive airway pressure (CPAP); Drug: Oxygen

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Hårdstedt, MD/PhD; Phone Number: 46-738089464; Email: maria.hardstedt@regiondalarna.se

Study Locations

• Sweden
  • Falun, Sweden, 79182
    • Recruiting
    • Center of Clinical Research Dalarna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxygen + CPAP-treatment	Combination product: Oxygen + continuous positive airway pressure (CPAP); Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment
Active Comparator: Oxygen-treatment	Drug: Oxygen; Oxygen: 20 min treatment followed by 10 min rest and assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in absolute peripheral oxygen saturation (%) before and after treatment	Change in peripheral oxygen saturation % (continuous variable) measured by pulse oximetry before and after treatment	change before versus after 20 min treatment followed by 10 min rest
Recovery (yes/no) after treatment	Recovery, defined by "peripheral oxygen saturation >95% after treatment" or no recovery, defined by "peripheral oxygen saturation ≤95% after treatment"	after 20 min treatment followed by 10 min rest
Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment	Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Bilateral or unilateral presence of two or more positive regions define positive interstitial syndrome.	after 20 min treatment followed by 10 min rest
Absolute number of regions presenting B-lines on lung ultrasound after treatment	Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Assessment of the total number of positive regions.	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	Four chest regions for both lungs are scanned by lung ultrasound; a positive region defined by the presence of three or more B-line artifacts. Assessment of the total number of positive regions. 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
Change in patient reported outcome measures before and after treatment	Six different patient reported outcome measures assessed by numeric rating scale (NRS) 0-10: cough, sputum, air hunger, breathing effort, tightness in chest, anxiousness. The patients will assess symptoms prior to and after treatment.	change before versus after 20 min treatment followed by 10 min rest
Admission to hospital (yes/no)	admission to hospital within or after a maximal treatment time of 40 minutes followed by 20 min rest.	2 hours
total treatment time	total treatment time until oxygen saturation ≥96% is reached.	2 hours
subgroup analysis	treatment outcome analysis in patients with different baseline oxygen saturation on admission	1 hour

Collaborators and Investigators

• Sponsor: Dalarna County Council, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2022
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: oxygen; ultrasonography; oximetry; therapeutics; continuous positive airway pressure (CPAP)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Edema; Edema
• Other Study ID Numbers: OCTOPUS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No