O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS)

רק משתמשים רשומים יכולים לתרגם מאמרים

התחבר הרשם

הקישור נשמר בלוח

סטָטוּסעדיין לא מגייס

נותני חסות

Dalarna County Council, Sweden

ניסוי קליני: NCT04307615

BioSeek: nct04307615

מילות מפתח

תַקצִיר

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.

תיאור

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 0,3%.

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.

תאריכים

אומת לאחרונה:	02/29/2020
הוגש לראשונה:	02/03/2020
ההרשמה המשוערת הוגשה:	03/10/2020
פורסם לראשונה:	03/12/2020
העדכון האחרון הוגש:	03/10/2020
עדכון אחרון פורסם:	03/12/2020
תאריך תחילת לימוד בפועל:	07/02/2020
תאריך סיום משוער משוער:	07/14/2022
תאריך סיום משוער ללימודים:	07/14/2022

מצב או מחלה

Swimming Induced Pulmonary Edema (SIPE)

Pulmonary Edema

Lung Diseases

התערבות / טיפול

Combination Product: Oxygen + CPAP-treatment

Drug: Oxygen-treatment

שלב

קבוצות זרועות

זְרוֹעַ	התערבות / טיפול
Experimental: Oxygen + CPAP-treatment	Combination Product: Oxygen + CPAP-treatment Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment
Active Comparator: Oxygen-treatment	Drug: Oxygen-treatment Oxygen: 20 min treatment followed by 10 min rest and assessment

קריטריונים לזכאות

גילאים הזכאים ללימודים	18 Years ל 18 Years
מינים הזכאים ללימודים	All
מקבל מתנדבים בריאים	כן
קריטריונים	Inclusion Criteria: - clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment (oxygen saturation ≤95%) - 18 years and older - informed consent Exclusion Criteria: - declined consent - SIPE without need of acute treatment (oxygen saturation >95%) - 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

תוֹצָאָה

מדדי תוצאות ראשוניים

1. Absolute peripheral oxygen saturation (%) after treatment [after 20 min treatment followed by 10 min rest]

Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry

אמצעי תוצאה משניים

1. Change in absolute peripheral oxygen saturation (%) before and after treatment [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

2. Recovery (yes/no) after treatment [after 20 min treatment followed by 10 min rest]

Recovery, defined by "peripheral oxygen saturation >95% after treatment" or no recovery, defined by "peripheral oxygen saturation ≤95% after treatment"

3. Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment [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.

4. Absolute number of regions presenting B-lines on lung ultrasound after treatment [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.

5. 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]

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

6. Auscultation findings of crackles (yes/no) after treatment [after 20 min treatment followed by 10 min rest]

Findings of crackles (yes/no) by lung auscultation after treatment

7. Change in individual assessment of symptoms before and after treatment [change before versus after 20 min treatment followed by 10 min rest]

Six different symptoms 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.

O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS)

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