Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function (PoccUS)
Estimation of Airway Occlusion Pressure at 100 ms Using Ultrasound Indexes of Diaphragm Function
Occlusion pressure at 100 ms (P0.1) is a reliable and non-invasive index of inspiratory drive that can be measured easily on most ventilator. Unfortunately, P0.1 cannot be measured reliably in non-intubated patients. In those receiving non-invasive ventilation, the measurement of P0.1 might be inaccurate due to leaks. P0.1 cannot be measured at all in patients receiving high-flow nasal canulae (HFNC).
Ultrasound indices of diaphragm contractile function, namely diaphragm excursion, velocity and thickening fraction, could be reliable and non-invasive proxies of respiratory drive in non-intubated patient.
Our hypothesis is that ultrasound indices of diaphragm function may reliably estimate P0.1. To validate this hypothesis, theses indices will be measured simultaneously with P0.1 in intubated patients, during diaphragm loading conditions similar to spontaneous breathing: the spontaneous breathing trial (SBT). The SBT is used to evaluate if patients can breathe without the assistance provided by the ventilator, and thus, be weaned from mechanical ventilation.
연구 개요
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- - Age ≥ 18 years old
- Patient intubated or tracheostomized
- Decision by the clinician in charge to initiate a SBT
- After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)
Exclusion Criteria:
- - Suspicion of diaphragmatic nerves injury
- Preexisting neuromuscular disease
- Spinal cord injury above C5
- Neuromuscular blockade within last 24 hours
- Body mass index > 40 kg/m2
- Pregnancy or breast feeding
- Patient under legal protection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT
기간: 5 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak contraction velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
5 minutes after the initiation of the SBT
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
P0.1 and EXdi
기간: Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to maximal excursion of the diaphragm, measured by subcostal ultrasound in M-mode
|
Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
|
P0.1 and Peak contraction velocity
기간: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak contraction velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
|
P0.1 and EXdi,0.1
기간: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to excursion of the diaphragm measured 100 ms after the beginning of the inspiration, measured by subcostal ultrasound in M-mode
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
|
P0.1 and Velocity Time Integral
기간: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to velocity time integral of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
|
P0.1 and Peak relaxation velocity
기간: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
|
P0.1 and Peak relaxation rate
기간: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation rate of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
|
P0.1 and TFdi
기간: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to thickening fraction of the diaphragm, measured by intercostal ultrasound in M-mode.
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
|
P0.1 and mean thickening velocity
기간: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to mean thickening velocity of the diaphragm, measured by intercostal ultrasound in M-mode.
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
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. .
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