Automated oxygen titration의 코로나바이러스감염증-19 : 코로나19 및 저산소증 및 저산소혈증 - 임상 시험 레지스트리

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

장치: Automated oxygen titration

상세 설명

The aim of this study is to evaluate the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department. The quality of oxygen therapy is evaluated by the time spent in the SpO2 target (+/- 2% SpO2 target), time spent in hyperoxemia (> 5% SpO2 target), time spent in hyperoxemia (<5% SpO2 target).

연구 유형

관찰

등록 (예상)

60

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: François Lellouche, MD, PhD
전화번호: 3572 418-656-8711
이메일: Francois.Lellouche@criucpq.ulaval.ca

연구 연락처 백업

이름: Léa Dallaire, MD
전화번호: 438-868-8022
이메일: lea.dallaire.1@ulaval.ca

연구 장소

캐나다
- - Québec, 캐나다, G1V 4G5
    - Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
    - 연락하다:
      
      François Lellouche, MD,PhD
      
      전화번호: 3572 418-656-8711
      
      이메일: francois.lellouche@criucpq.ulaval.ca
    - 수석 연구원:
      
      François Lellouche, Md,PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Confirmed or suspected SARS-CoV-2 patient aged 18 years old or older on automated oxygen therapy in the emergency department.

설명

Inclusion Criteria:

Hypoxemic patients on automated oxygen therapy during their emergency department stay
Confirmed or suspected SARS-CoV-2 patients in the emergency department

Exclusion Criteria:

Patient on automated oxygen therapy in the emergency department without accessible data of the FreeO2 device.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Percentage of time in the saturation target in patients on automated oxygen titration device. 기간: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission	The percentage of time in target is defined by the percentage of time of (Target - 3% target) < SpO2 value < (Target + 3%) of the selected Spo2 target using automated oxygen titration device.	From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission

2차 결과 측정

결과 측정	측정값 설명	기간
Oxygenation data - hyperoxemia 기간: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission	The percentage of time in hyperoxemia defined as a SpO2 value > 5% from the target.	From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Oxygenation data - severe hypoxemia 기간: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission	The percentage of time in hypoxemia defined as a SpO2 value < 85%	From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Oxygenation data - mild hypoxemia 기간: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission	The percentage of time in mild hypoxemia defined as a : (Target - 5% target) < SpO2 value < (Target - 2%)	From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
automated oxygen therapy duration 기간: From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission	Length of total time on automated oxygen therapy in the emergency department in hours.	From the initiation of oxygen therapy with FreeO2 until the date of emergency department discharge or Stop of oxygen therapy with FreeO2 whichever came first, assessed up to 3 day after emergency admission
Ventilatory support 기간: From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission	Need of change in ventilatory support device : (mechanical ventilation, non-invasive mechanical ventilation, high flow nasal canula, oxygen therapy) during emergency length of stay	From the initiation of oxygen therapy with FreeO2 until hospital discharge, assessed up to 2 months after emergency admission
Emergency length of stay. 기간: From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admission	Time of stay in hours in the emergency department.	From emergency departement admission until the date of emergency department discharge assessed up to 3 day after emergency admission
Hospital length of stay. 기간: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission	Time of stay in hours during hospitalisation Time of stay in hospitalisation setting (excluding the intensive care unit) and intensive care unit in days.	From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission
Orientation of care 기간: From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission	Describe departement admission (emergency observation, general ward ,intensive care unit)	From emergency departement admission until the date of hospital discharge assessed up to 2 months after emergency admission

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Laval University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (예상)

2022년 2월 1일

기본 완료 (예상)

2022년 3월 1일

연구 완료 (예상)

2022년 12월 1일

연구 등록 날짜

최초 제출

2022년 2월 3일

QC 기준을 충족하는 최초 제출

2022년 2월 9일

처음 게시됨 (실제)

2022년 2월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)