- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03395782
Factors Determining Oxygen Wash in During Pre-oxygenation
Factors Determining End-tidal O2 Concentration in During Pre-oxygenation
연구 개요
상태
정황
상세 설명
Before induction of general anaesthesia pre-oxygenation is a recommended procedure to enhance the time available for solving a problem with the airway or intubation during induction. This can be accomplished by letting the patient breath normal tidal volumes with 100% oxygen for 3 to 5 minutes during pre-oxygenation. If there is airway closure during tidal volume breathing, pre-oxygenation needs longer time to achieve a maximum effect. Airway closure increases with advanced age and a few earlier studies has also shown a correlation between older age and longer time for the rise in the end-tidal O2 concentration during pre-oxygenation.
Pre-oxygenation is a strongly recommended safety procedure before starting anaesthesia but has at least one major side affect: it is the main reason for the development of atelectasis in the lungs during anaesthesia. Atelectasis impairs oxygenation during anaesthesia and probably increase the risk for postoperative pulmonary complications.
Postoperative complications are more common with advanced age and it is important to understand the mechanisms and risk factors involved.
In this study, the investigators hypothesise that the PaO2 as measured before the start of pre-oxygenation, with the patient breathing air, is a better predictor than age for estimating the time necessary for achieving the goal of pre-oxygenation. If this assumption is correct it might have implication for how pre-oxygenation should be adjusted with advancing age.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Västmanland
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Köping, Västmanland, 스웨덴, 73130
- Köping County Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients scheduled for general anaesthesia in American Society of Anesthesiology (ASA) physical status classification grade I-III.
- Body mass index over 18.5 and less than 30 kg/m2
- Peripheral oxygen saturation 92% or more on air.
Exclusion Criteria:
- ASA IV.
- Patients with active smoking and former smokers with a history of smoking more than 6 pack-years.
- Chronic obstructive lung disease.
- Bloodgas with PaO2 ≤ 8 kilopascal (kPa) or PaCO2 ≥ 6.5 kPa.
- Continuous positive airway pressure treatment at night.
- Heart failure or angina pectoris.
- Hemoglobin value less than 100 g/L.
- Pregnancy.
- Any neuromuscular or neurologic illness reducing ventilatory capacity.
- Any endocrine disease influencing basic metabolic demand.
- Not possible to achieve a tight mask seal.
- Patient unable to follow instructions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
|---|
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Age group 40-49
30 patients will be stratified to this age group.
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Age group 50-59
30 patients will be stratified to this age group.
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Age group 60-69
30 patients will be stratified to this age group.
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Age group 70-79
30 patients will be stratified to this age group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PaO2 breathing air before start of pre-oxygenation and the rise in end-tidal O2 during pre-oxygenation.
기간: 5 minutes.
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An arterial bloodgas with the patient in the supine position breathing air will be analysed with regards to PaO2 and correlated to the rise in end-tidal O2 concentration during pre-oxygenation.
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5 minutes.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Age and the rise in end-tidal O2 during pre-oxygenation.
기간: 5 minutes.
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Age will be correlated to the rise in end-tidal O2 during pre-oxygenation.
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5 minutes.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lennart Edmark, Ph.D., Region Västmanland
간행물 및 유용한 링크
일반 간행물
- Kang H, Park HJ, Baek SK, Choi J, Park SJ. Effects of preoxygenation with the three minutes tidal volume breathing technique in the elderly. Korean J Anesthesiol. 2010 Apr;58(4):369-73. doi: 10.4097/kjae.2010.58.4.369. Epub 2010 Apr 28.
- Sum Ping SJ, Makary LF, Van Hal MD. Factors influencing oxygen store during denitrogenation in the healthy patient. J Clin Anesth. 2009 May;21(3):183-9. doi: 10.1016/j.jclinane.2008.07.004.
- Milic-Emili J, Torchio R, D'Angelo E. Closing volume: a reappraisal (1967-2007). Eur J Appl Physiol. 2007 Apr;99(6):567-83. doi: 10.1007/s00421-006-0389-0. Epub 2007 Jan 20.
- Gambee AM, Hertzka RE, Fisher DM. Preoxygenation techniques: comparison of three minutes and four breaths. Anesth Analg. 1987 May;66(5):468-70. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
이 연구와 관련된 용어
기타 연구 ID 번호
- 20170517-184
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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