- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04799132
Association Between Body Mass Index and HFNC Therapy Success
2021년 3월 11일 업데이트: Carlos Augusto Celemín Florez, MD., Clínica del country
Association Between Body Mass Index and High-flow Cannula Therapy Success in Patients With Severe Covid 19 Related Pneumonia. Retrospective Study.
Patients over 18 years of age who are admitted to the Intermediate Care Unit of the Clinica del Country and the Clinica la Colina, with symptoms suggestive of severe pneumonia secondary to COVID-19 infection and acute hypoxemic respiratory failure.
The primary outcome will be to determine the relationship between body mass index and high-flow cannula therapy success defined as: No need for mechanical ventilation.
연구 개요
상세 설명
All adult patients over 18 years of age admitted to the intermediate care service of the participating center with suspected SARS-CoV-2 pneumonia will be considered as potential candidates for the study.
The medical records of patients in our cohort who require high-flow cannula therapy and who met all the inclusion criteria and none of the exclusion criteria will be reviewed.All data will be processed and analyzed using the SPSS 26 software once the study is completed. study sample
연구 유형
관찰
등록 (실제)
303
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bogotá, 콜롬비아
- Clínica del Country.
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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
Patients over 18 years of age who are admitted to the Intermediate Care Unit of the Clinica del Country and the Clinica la Colina, with symptoms suggestive of severe pneumonia secondary to COVID-19 infection and acute hypoxemic respiratory failure.
설명
Inclusion Criteria:
- Patients over 18 years of age.
- Diagnosis of severe pneumonia secondary to COVID-19 infection and acute respiratory distress syndrome, defined by upper and lower respiratory symptoms plus positive C-reactive protein test for COVID-19.
- Patient admission to the Clinical del Country and Clinica de la Colina intermediate care units.
- Oxygen therapy by high-flow system (high-flow cannula) requirement.
- Anthropometric data availability upon admission to our facilities.
Exclusion Criteria:
- Patients with a survival expectancy of less than 12 months according to the Charlson scale categorization or patients with oncological pathology.
- Patients under 18 years of age.
- Pregnant women.
- Patients with cardiogenic pulmonary edema.
- History of chronic liver disease or cirrhosis Child - Pugh C.
- Patients with contraindications to high-flow cannula therapy initiation.
- Patients with respiratory, hemodynamic and neurological indications that contraindicate HFNC initiation.
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 |
---|---|---|
Primary outcome
기간: 1 year.
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To determine the relationship between body mass index "BMI" calculated by kg / m2 (BMI was classified in the following categories: normal weight: 18.5-24.9
kg / m2, overweight: 25-29.9
kg / m2, and obesity: ≥ 30 kg / m2) and high-flow cannula therapy success defined as: No need for mechanical ventilation.
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1 year.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Demographic and laboratory characteristics
기간: 1 year
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Describe the clinical, demographic and laboratory characteristics in a population of 303 patients in Bogotá, Colombia with severe pneumonia defined by ATS criteria (confusion, urea >7 mmol/L, respiratory rate ≥30 min-1, low blood pressure, and age ≥65 years) score except age, arterial oxygen pressure/fraction inspired oxygen (PaO2/FiO2) ≤250 mmHg, multilobar infiltrates, leucopenia, thrombocytopenia, and hypothermia.)
secondary to COVID 19 infection (positive C-Reactive protein) and acute hypoxemic respiratory failure defined by a PaFio2 < 300, in the intermediate care service of the Clínica del Country and Clínica La Colina, between March 2020 and March 2021.
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1 year
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Body mass index as a predictor
기간: 1 year
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Evaluate the body mass index as a predictor of success in high-flow cannula therapy.
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1 year
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Body mass index and HFNC success
기간: 1 year
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Evaluate the relationship between body mass index and high-flow nasal cannula therapy success.
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1 year
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Mortality
기간: 1 year
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Describe the mortality of patients with high-flow cannula therapy in our medical facilities.
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1 year
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Hospital stay.
기간: 1 year
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The relationship between hospital stay (days) and body mass index in our patients' cohort will be evaluated.
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1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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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 (실제)
2020년 3월 11일
기본 완료 (실제)
2021년 3월 1일
연구 완료 (실제)
2021년 3월 1일
연구 등록 날짜
최초 제출
2021년 3월 9일
QC 기준을 충족하는 최초 제출
2021년 3월 11일
처음 게시됨 (실제)
2021년 3월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 3월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 3월 11일
마지막으로 확인됨
2021년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BMI AND HFNC
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .