Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia (PRIOR-Trauma)
Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study
Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.
It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.
Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.
Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.
The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Malin Jonsson Fagerlund
- 전화번호: 0707691405
- 이메일: malin.jonsson-fagerlund@sll.se
연구 장소
-
-
-
Stockholm, 스웨덴, SE-17176
- 모병
- Karolinska University Hospital Solna
-
연락하다:
- Malin Jonsson Fagerlund
- 전화번호: +46707691405
- 이메일: malin.jonsson.fagerlund@ki.se
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 1 Adult, ≥18 years old
- 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).
Exclusion Criteria:
- 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Tight fitting facemask
Preoxygenation with tight facemask, 100% oxygen.
|
Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
|
|
High flow nasal oxygen
Preoxygenation with high flow nasal oxygen, 100% oxygen
|
Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of patients with a peripheral oxygen saturation (SpO2) below 93%
기간: From start of anaesthesia until 1 minute after tracheal intubation.
|
Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.
|
From start of anaesthesia until 1 minute after tracheal intubation.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Lowest median SpO2.
기간: From start of anaesthesia until 1 minute after tracheal intubation.
|
Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation
|
From start of anaesthesia until 1 minute after tracheal intubation.
|
|
End tidal gas levels
기간: At the first breath after tracheal intubation.
|
Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.
|
At the first breath after tracheal intubation.
|
|
Time span from start of preoxygenation until intubation.
기간: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.
|
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
|
Time span from entering trauma room until intubation.
기간: Could vary depending on patient and trauma, from a couple of minutes up to an hour.
|
Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.
|
Could vary depending on patient and trauma, from a couple of minutes up to an hour.
|
|
Difficulties with induction of anaesthesia
기간: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula
|
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
|
Frequency of complications
기간: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
Frequency of complications (aspiration, signs of intraabdominal/intracranial gas, difficulties intubating the trachea, hypotension) in the HFNO group compared to the group preoxygenated with traditional facemask.
|
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Malin Jonsson Fagerlund, Karolinska University Hospital and Karolinska Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- PRIOR-Trauma
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
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. .