O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS) (OCTOPUS)
Evaluatie van continue positieve luchtwegdruk (CPAP) bij door zwemmen geïnduceerd longoedeem (SIPE) - een gerandomiseerde enkelblinde gecontroleerde studie
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Maria Hårdstedt, MD/PhD
- Telefoonnummer: 46-738089464
- E-mail: maria.hardstedt@regiondalarna.se
Studie Locaties
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Falun, Zweden, 79182
- Werving
- Center of Clinical Research Dalarna
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Zuurstof + CPAP-behandeling
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Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment |
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Actieve vergelijker: Zuurstofbehandeling
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Oxygen: 20 min treatment followed by 10 min rest and assessment |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Absolute peripheral oxygen saturation (%) after treatment
Tijdsspanne: after 20 min treatment followed by 10 min rest
|
Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry |
after 20 min treatment followed by 10 min rest
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in absolute peripheral oxygen saturation (%) before and after treatment
Tijdsspanne: change before versus after 20 min treatment followed by 10 min rest
|
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
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Recovery (yes/no) after treatment
Tijdsspanne: after 20 min treatment followed by 10 min rest
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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
|
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Absolute number of regions presenting B-lines on lung ultrasound after treatment
Tijdsspanne: after 20 min treatment followed by 10 min rest
|
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
Tijdsspanne: change before versus after 20 min treatment followed by 10 min rest
|
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
|
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Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
Tijdsspanne: after 20 min treatment followed by 10 min rest
|
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
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Change in patient reported outcome measures before and after treatment
Tijdsspanne: change before versus after 20 min treatment followed by 10 min rest
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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
|
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Admission to hospital (yes/no)
Tijdsspanne: 2 hours
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admission to hospital within or after a maximal treatment time of 40 minutes followed by 20 min rest. |
2 hours
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total treatment time
Tijdsspanne: 2 hours
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total treatment time until oxygen saturation ≥96% is reached. |
2 hours
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subgroup analysis
Tijdsspanne: 1 hour
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treatment outcome analysis in patients with different baseline oxygen saturation on admission |
1 hour
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Medewerkers en onderzoekers
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Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OCTOPUS001
Plan Individuele Deelnemersgegevens (IPD)
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