- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03698799
Adherence to LPV in SICU and Associated Clinical Outcomes
2020년 6월 3일 업데이트: Annop Piriyapatsom, MD, Mahidol University
Adherence Rate to Lung Protective Mechanical Ventilation in Patients Admitted to Surgical Intensive Care Units and Associated Clinical Outcomes
Lung Protective Ventilation strategy (LPV) with low tidal volume and adequate positive end-expiratory pressure is recommended for not only patients with acute respiratory distress syndrome (ARDS) but also those without ARDS too.
From previous studies, adherence to LPV strategy reported is only 40% and data is limited in surgical patients.
The investigators aim to describe ventilation management and find out the adherence rate to LPV strategy applied to surgical patients admitted to the surgical intensive care unit (SICU) and their associated outcomes.
연구 개요
상세 설명
Mechanical ventilation (MV) is one of the one organ support most frequently applied to patients admitted to intensive care units (ICUs).
Despite considering as a life-saving intervention, MV may have detrimental effects, namely ventilator-induced lung injury (VILI).
A mechanical breath with positive airway pressure may overstretch alveoli, especially in the non-dependent part of the lungs, and subsequently result in barotrauma and volutrauma.
While cyclic opening and closing of alveoli during mechanical breath due to alveolar collapse at the end of expiration can cause atelec-trauma or cyclic atelectasis.
All of these can lead to the activation of respiratory and systemic inflammatory response, so-called bio-trauma.
To minimize the effects of MV on VILI, the lung protective mechanical ventilation (LPV) strategy have been proposed and now generally accepted as a standard practice in mechanically ventilated patients.
The LPV strategy basically consists of ventilation with the low tidal volume of 6-8 mL/kg of predicted body weight (PBW) with limited plateau pressure of less than 30 cm H2O plus applying sufficient amount of positive end-expiratory pressure (PEEP) to prevent atelectasis.
The LPV strategy has been clearly demonstrated benefits in not only patients with acute respiratory distress syndrome (ARDS) but also those with normal lungs including lessened respiratory and systemic inflammatory response and injured lungs, decreased duration of MV and length of stay (LOS), improved organ failure, and decreased pulmonary and other complications as well as mortality.
Nevertheless, the adherence rate to the LPV strategy reported in the literatures is only approximately 40% in mechanically ventilated patients.
For surgical patients, approximately 65% of those admitted to ICU require MV support either following operation or during their stay in ICU.
To date, there is limited data regarding MV management in surgical patients who required MV support perioperatively.
In addition, the difference in perioperative MV practices and their associated clinical outcomes has been not well determined in this setting.
The aim of this study is to explore the current practice of MV according to the LPV strategy applied to surgical patients admitted to surgical ICU (SICU) and their associated clinical outcome.
The primary outcome of this study is to determine the adherence rate to the LPV strategy at the initiation of MV support in mechanically ventilated patients in SICU.
The LPV strategy in this study is defined as ventilation with the tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm of water.
The secondary outcomes are factors associated with the adherence to the LPV strategy, incidences of pulmonary and other complications, LOS in SICU and in hospital, SICU and hospital discharge status, and status at 28 and 90 days following the initiation of MV support.
Patients are divided into two groups, LPV and Non-LPV, according to their MV setting and clinical outcomes are statistically compared between groups.
연구 유형
관찰
등록 (실제)
306
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bangkok
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Bangkoknoi, Bangkok, 태국, 10700
- Siriraj Hospital
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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
All patients whose age of 18 years old or more admitted to two participating SICU and requiring MV support, either at SICU admission or during stay in SICU, via either endotracheal or tracheostomy tube with the anticipated duration of 12 hours or more without exclusion criteria are included.
설명
Inclusion Criteria:
- Patients whose age of 18 years old or more
- Patients admitted to two participating SICU
- Patients requiring MV support with the anticipated duration of 12 hours or more
Exclusion Criteria:
- Patients not requiring MV support during SICU stay
- Patients requiring MV support for less than 12 hours in SICU
- Patients requiring MV support for more than 24 hours prior to SICU admission
- Patients included in this study once and re-admitted to the SICU
- Patients requiring non-invasive MV support
- Moribund or terminal cases
- Patients who refuse to participate in the study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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LPV
Patients receive LPV strategy at the initiation of MV support.
The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O.
|
Non-LPV
Patients do not receive LPV strategy at the initiation of MV support.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adherence rate to LPV strategy at the initiation of MV support
기간: During the first 24 hours following the initiation of MV support
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The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O.
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During the first 24 hours following the initiation of MV support
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidences of pulmonary and other complications
기간: During the first 7 consecutive days following the initiation of MV support
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Pulmonary complications include pneumonia, ARDS, atelectasis, restoration of MV support after liberation from MV, pleural effusion, cardiogenic pulmonary edema, pneumothorax and new pulmonary infiltration.
Other complications include stroke, myocardial ischemia/infarction, arrhythmias, acute kidney injury, sepsis, new infection other than pneumonia, and re-admission to the SICU.
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During the first 7 consecutive days following the initiation of MV support
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Length of stay in SICU and in hospital
기간: Up to 90 days following the initiation of MV support
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Total days of stay in SICU and in hospital following the initiation of MV support.
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Up to 90 days following the initiation of MV support
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SICU and hospital discharge status, and status at 28 and 90 days
기간: Up to 90 days following the initiation of MV support
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Status whether alive or decease
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Up to 90 days following the initiation of MV support
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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
- Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
- Petrucci N, De Feo C. Lung protective ventilation strategy for the acute respiratory distress syndrome. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD003844. doi: 10.1002/14651858.CD003844.pub4.
- Sutherasan Y, Vargas M, Pelosi P. Protective mechanical ventilation in the non-injured lung: review and meta-analysis. Crit Care. 2014 Mar 18;18(2):211. doi: 10.1186/cc13778. No abstract available.
- Biehl M, Kashiouris MG, Gajic O. Ventilator-induced lung injury: minimizing its impact in patients with or at risk for ARDS. Respir Care. 2013 Jun;58(6):927-37. doi: 10.4187/respcare.02347.
- Terragni P, Ranieri VM, Brazzi L. Novel approaches to minimize ventilator-induced lung injury. Curr Opin Crit Care. 2015 Feb;21(1):20-5. doi: 10.1097/MCC.0000000000000172.
- Wang C, Wang X, Chi C, Guo L, Guo L, Zhao N, Wang W, Pi X, Sun B, Lian A, Shi J, Li E. Lung ventilation strategies for acute respiratory distress syndrome: a systematic review and network meta-analysis. Sci Rep. 2016 Mar 9;6:22855. doi: 10.1038/srep22855.
- Neto AS, Simonis FD, Barbas CS, Biehl M, Determann RM, Elmer J, Friedman G, Gajic O, Goldstein JN, Linko R, Pinheiro de Oliveira R, Sundar S, Talmor D, Wolthuis EK, Gama de Abreu M, Pelosi P, Schultz MJ; PROtective Ventilation Network Investigators. Lung-Protective Ventilation With Low Tidal Volumes and the Occurrence of Pulmonary Complications in Patients Without Acute Respiratory Distress Syndrome: A Systematic Review and Individual Patient Data Analysis. Crit Care Med. 2015 Oct;43(10):2155-63. doi: 10.1097/CCM.0000000000001189.
- Santamaria JD, Tobin AE, Reid DA. Do we practise low tidal-volume ventilation in the intensive care unit? a 14-year audit. Crit Care Resusc. 2015 Jun;17(2):108-12.
- Kalhan R, Mikkelsen M, Dedhiya P, Christie J, Gaughan C, Lanken PN, Finkel B, Gallop R, Fuchs BD. Underuse of lung protective ventilation: analysis of potential factors to explain physician behavior. Crit Care Med. 2006 Feb;34(2):300-6. doi: 10.1097/01.ccm.0000198328.83571.4a.
- Umoh NJ, Fan E, Mendez-Tellez PA, Sevransky JE, Dennison CR, Shanholtz C, Pronovost PJ, Needham DM. Patient and intensive care unit organizational factors associated with low tidal volume ventilation in acute lung injury. Crit Care Med. 2008 May;36(5):1463-8. doi: 10.1097/CCM.0b013e31816fc3d0.
- Chen YF, Lim CK, Ruan SY, Jerng JS, Lin JW, Kuo PH, Wu HD, Yu CJ. Factors associated with adherence to low-tidal volume strategy for acute lung injury and acute respiratory distress syndrome and their impacts on outcomes: an observational study and propensity analysis. Minerva Anestesiol. 2014 Nov;80(11):1158-68. Epub 2014 Feb 25.
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)
2018년 4월 9일
기본 완료 (실제)
2019년 6월 30일
연구 완료 (실제)
2020년 3월 20일
연구 등록 날짜
최초 제출
2018년 9월 27일
QC 기준을 충족하는 최초 제출
2018년 10월 5일
처음 게시됨 (실제)
2018년 10월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 6월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 3일
마지막으로 확인됨
2020년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 077/2561(EC4)
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