- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02352376
Noninvasive Ventilation After Coronary Bypass Grafting (Physiotherapy)
2015년 1월 28일 업데이트: Célia Regina Lopes, Federal University of Uberlandia
Effects of Non Invasive Ventilation on Heart Rate Variability After Coronary Bypass Grafting: Comparison Between Different Ventilator
This is a prospective, quantitative, randomized, crossover study.
Were included in this study 10 people in the Intensive Care Unit at University Hospital in Uberlandia, on the first day of the postoperative coronary artery bypass graft (CABG).
For data collection was performed randomization on the block (2: 4), to determine the first technique to be used and then a wash-out period of one hour was allowed for the research subject reaches the systemic arterial pressure, heart rate, respiratory rate and oxygen saturation baseline.
And after, for cross-over, the second technique was performed.
Non-invasive ventilation was performed for 30 minutes each ventilator.
All subjects underwent noninvasive ventilation using two models of ventilators, they are conventional (designed for invasive ventilation but is also used in non-invasive ventilation mode) and specific (designed for non-invasive ventilation).
Hemodynamic, autonomic and respiratory variables are monitored.
We use the hypothesis that non-invasive ventilation performed with two fan models can alter autonomic function and that there is hemodynamic changes related to autonomic function in different ventilators in postoperative coronary artery bypass grafting.
연구 개요
상세 설명
Background: The patients in postoperative coronary artery bypass graft (CABG) have impaired cardiac autonomic function.
However, no studies have evaluated the influence of different ventilators during noninvasive ventilation (NIV) in the autonomic modulation associated with hemodynamic changes.
Objective: Evaluate the autonomic behavior and hemodynamic changes during the execution of the NIV with two models of mechanical ventilators in subjects after CABG.
Material and Methods: This is quantitative randomized, prospective, crossover study.
The subjects were selected on first day postoperatively CABG and was performance NIV procedure using two different ventilators: conventional ventilator and specific ventilator for the use of NIV for 30 minutes, each.
Block randomization was used to determine the technique that begins to approach then by crossover, perform the sequential technique.
The heart rate variability (HRV), heart rate, respiratory rate, oxygen peripheral saturation and arterial pressure were evaluated before procedure, in the instants 5, 10, 15, 20, 25, 30 minutes during NIV each and 15 minutes after the end of the NIV application.
HRV was evaluated using the time and frequency domain.
연구 유형
중재적
등록 (실제)
10
단계
- 4단계
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
설명
Inclusion criteria
- Age over 18 years .Who were breathing spontaneously with peripheral oxygen saturation (SpO2) ≥ 90% and supplemental oxygen ≤ 3 l / min.
- Indication for use of NIV
Exclusion criteria
- Hemodynamic instability with hypertensive response being considered systolic blood pressure (SBP) greater than 180 mmHg and diastolic blood pressure (DBP) greater than 110 mmHg, or difference in SBP and DBP less than 20 mmHg or framework shock considering SBP <90 mmHg and / or DBP <50 mmHg, since the normal SBP were between 90-130 mmHg and DBP 60-90 mmHg
- Presence of active cardiac pacemaker
- Invasive mechanical ventilation more than 24 hours
- Use of intra aortic balloon
- Postoperatively Myocardial infarction after surgery
- Ineffective cough with bronchial hypersecretion
- Inability to adequately swallowing and/or protect the airway
- Abdominal distension
- Nausea
- Vomiting
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Conventional ventilator
30 minutes of non-invasive ventilation was performed with conventional ventilator.The order of the procedures was determined by randomization.
|
A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).
A ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak
|
|
다른: Specific ventilator
30 minutes of non-invasive ventilation was performed with specific respirator.
The order of the procedures was determined by randomization.
|
A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).
A ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Variability of heart rate front the use of noninvasive ventilation in two different ventilators in patients after cardiac surgery, measured by Polar RS800 CX.
기간: 3 hours
|
The autonomic variables evaluated are: standard deviation of all normal RR intervals recorded in a time interval (SDNN); standard deviation of the mean of normal RR intervals every 5 minutes at a time, expressed in milliseconds (SDANN); percentage of R-Ri with adjacent difference of duration greater than 50 milliseconds (pNN50) and the square root of the average squared difference between the adjacent R-Ri normal in a period of time, expressed in milliseconds (rMSSD).
All variables will be assessed by Polar RS800CX
|
3 hours
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in the indices of variability of heart rate, systolic blood pressure, diastolic blood pressure and heart rate during noninvasive ventilation with two models of ventilatotors in patients after cardiac surgery.
기간: 3 hours
|
3 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Valdeci C Dionísio, Dr., Federal University of Uberlândia
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
- Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
- Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.
- Zhu GF, Wang DJ, Liu S, Jia M, Jia SJ. Efficacy and safety of noninvasive positive pressure ventilation in the treatment of acute respiratory failure after cardiac surgery. Chin Med J (Engl). 2013 Dec;126(23):4463-9.
- Ozyilmaz E, Ugurlu AO, Nava S. Timing of noninvasive ventilation failure: causes, risk factors, and potential remedies. BMC Pulm Med. 2014 Feb 13;14:19. doi: 10.1186/1471-2466-14-19.
- Carnevali L, Sgoifo A. Vagal modulation of resting heart rate in rats: the role of stress, psychosocial factors, and physical exercise. Front Physiol. 2014 Mar 24;5:118. doi: 10.3389/fphys.2014.00118. eCollection 2014.
- Pantoni CB, Di Thommazo L, Mendes RG, Catai AM, Luzzi S, Amaral Neto O, Borghi-Silva A. Effects of different levels of positive airway pressure on breathing pattern and heart rate variability after coronary artery bypass grafting surgery. Braz J Med Biol Res. 2011 Jan;44(1):38-45. doi: 10.1590/s0100-879x2010007500129. Epub 2010 Nov 19.
- Sasaki K, Maruyama R. Consciously controlled breathing decreases the high-frequency component of heart rate variability by inhibiting cardiac parasympathetic nerve activity. Tohoku J Exp Med. 2014 Jul;233(3):155-63. doi: 10.1620/tjem.233.155.
- Radaelli A, Raco R, Perfetti P, Viola A, Azzellino A, Signorini MG, Ferrari AU. Effects of slow, controlled breathing on baroreceptor control of heart rate and blood pressure in healthy men. J Hypertens. 2004 Jul;22(7):1361-70. doi: 10.1097/01.hjh.0000125446.28861.51.
- Pinsky MR. Cardiovascular issues in respiratory care. Chest. 2005 Nov;128(5 Suppl 2):592S-597S. doi: 10.1378/chest.128.5_suppl_2.592S.
- Yang LX, Zhou YJ, Wang ZJ, Li YP, Chai M. Impact of invasive treatment strategy on health-related quality of life six months after non-ST-elevation acute coronary syndrome. J Geriatr Cardiol. 2014 Sep;11(3):206-11. doi: 10.11909/j.issn.1671-5411.2014.03.003.
- Yan TD, Padang R, Poh C, Cao C, Wilson MK, Bannon PG, Vallely MP. Drug-eluting stents versus coronary artery bypass grafting for the treatment of coronary artery disease: a meta-analysis of randomized and nonrandomized studies. J Thorac Cardiovasc Surg. 2011 May;141(5):1134-44. doi: 10.1016/j.jtcvs.2010.07.001. Epub 2010 Dec 17.
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
2013년 3월 1일
기본 완료 (실제)
2014년 7월 1일
연구 완료 (실제)
2014년 11월 1일
연구 등록 날짜
최초 제출
2014년 11월 10일
QC 기준을 충족하는 최초 제출
2015년 1월 28일
처음 게시됨 (추정)
2015년 2월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 2월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 1월 28일
마지막으로 확인됨
2015년 1월 1일
추가 정보
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. .