수영 유도 폐부종(SIPE) 치료용 PEP 장치
수영 유도 폐부종(SIPE) 치료를 위한 양성 호기 압력 장치(PEP 장치)의 평가 - 무작위 단일 맹검 대조 연구
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 treatment with positive expiratory pressure device (PEP-device) compared to spontaneous recovery in patients with SIPE without hypoxia in the out-of-hospital environment.
연구 개요
상세 설명
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 or without oxygen in combination with diuretics, beta-agonist-inhalation or continuous positive airway pressure (CPAP). Evidence for optimal treatment strategy is lacking. Oxygen treatment might not be appropriate for patients with SIPE presenting without hypoxia. It is unknown if positive airway pressure accelerates recovery in SIPE.
This study intends to determine whether treatment with positive expiratory pressure (PEP) applied by PEP-device accelerates increase of oxygen saturation compared to spontaneous recovery in patients presenting with SIPE without hypoxia. 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 and oxygen saturation ≥92% are randomly assigned to 2 groups: (1) PEP-device for 20 minutes or (2) control group with spontaneous recovery without active treatment for 20 minutes. Assessment with outcome measures is taken 10 minutes after intervention/control. Primary endpoint: oxygen saturation (%) by pulse oxymetry.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Maria Hårdstedt, MD/PhD
- 전화번호: 46-738089464
- 이메일: maria.hardstedt@regiondalarna.se
연구 장소
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Falun, 스웨덴, 79182
- 모병
- Center of Clinical Research Dalarna
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연락하다:
- Maria Hårdstedt, MD/PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- clinical diagnosis of swimming induced pulmonary edema (SIPE) with need of acute treatment
- peripheral oxygen saturation ≥92%
- 18 years or older
- informed consent
Exclusion Criteria:
- declined consent
- suspected acute coronary syndrome
- severe asthma diagnosed together with pulmonary edema with requirement of beta-agonist-inhalation prior to treatment of pulmonary edema
- hemodynamic instability or decreased consciousness
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: PEP-device
Positive expiratory pressure device: continuous treatment with PEP-device breathing air for 20 minutes followed by 10 minutes rest and assessment. Inspiration through nose/mouth, expiration through device. |
PEP-device |
|
간섭 없음: spontaneous recovery
Control group: Resting and breathing air for 20 + 10 minutes. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Absolute peripheral oxygen saturation (%) after treatment
기간: after 20 min treatment followed by 10 min rest
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Peripheral oxygen saturation % (continuous variable) measured by peripheral pulse oximetry |
after 20 min treatment followed by 10 min rest
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in absolute peripheral oxygen saturation (%) before and after treatment
기간: 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
|
|
Recovery (yes/no) after treatment
기간: 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" |
after 20 min treatment followed by 10 min rest
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Interstitial syndrome assessed by lung ultrasound (yes/no) after treatment
기간: after 20 min treatment followed by 10 min rest
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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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Absolute number of regions presenting B-lines on lung ultrasound after treatment
기간: 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
기간: 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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Change in patient reported outcome measures before and after treatment
기간: change before versus after 20 min treatment followed by 10 min rest
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Six different patient reported outcome measures assessed by numerical rating scale (NRS; min-max 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)
기간: 1 hour
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Admission to hospital within or after a maximal treatment time of 1 hour |
1 hour
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Total treatment time
기간: 1 hour
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Total treatment time until oxygen saturation ≥96% is reached |
1 hour
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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