- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03698799
Adherence to LPV in SICU and Associated Clinical Outcomes
3 czerwca 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
306
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Bangkok
-
Bangkoknoi, Bangkok, Tajlandia, 10700
- Siriraj Hospital
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Adherence rate to LPV strategy at the initiation of MV support
Ramy czasowe: During the first 24 hours following 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.
|
During the first 24 hours following the initiation of MV support
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidences of pulmonary and other complications
Ramy czasowe: During the first 7 consecutive days following the initiation of MV support
|
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.
|
During the first 7 consecutive days following the initiation of MV support
|
|
Length of stay in SICU and in hospital
Ramy czasowe: Up to 90 days following the initiation of MV support
|
Total days of stay in SICU and in hospital following the initiation of MV support.
|
Up to 90 days following the initiation of MV support
|
|
SICU and hospital discharge status, and status at 28 and 90 days
Ramy czasowe: Up to 90 days following the initiation of MV support
|
Status whether alive or decease
|
Up to 90 days following the initiation of MV support
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
9 kwietnia 2018
Zakończenie podstawowe (Rzeczywisty)
30 czerwca 2019
Ukończenie studiów (Rzeczywisty)
20 marca 2020
Daty rejestracji na studia
Pierwszy przesłany
27 września 2018
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 października 2018
Pierwszy wysłany (Rzeczywisty)
9 października 2018
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 czerwca 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 czerwca 2020
Ostatnia weryfikacja
1 czerwca 2020
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 077/2561(EC4)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .