Perioperative/Postoperative Complications Clinical Trial
Official title:
Adherence Rate to Lung Protective Mechanical Ventilation in Patients Admitted to Surgical Intensive Care Units and Associated Clinical Outcomes
NCT number | NCT03698799 |
Other study ID # | 077/2561(EC4) |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 9, 2018 |
Est. completion date | March 20, 2020 |
Verified date | June 2020 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 306 |
Est. completion date | March 20, 2020 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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. Review. — View Citation
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 propen — View Citation
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. — View Citation
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. Review. — View Citation
Petrucci N, De Feo C. Lung protective ventilation strategy for the acute respiratory distress syndrome. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD003844. doi: 10.1002/14651858.CD003844.pub4. Review. — View Citation
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. — View Citation
Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito 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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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):146 — View Citation
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. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence rate to 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. | During the first 24 hours following the initiation of MV support | |
Secondary | Incidences of pulmonary and other complications | 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 | |
Secondary | Length of stay in SICU and in hospital | 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 | |
Secondary | SICU and hospital discharge status, and status at 28 and 90 days | Status whether alive or decease | Up to 90 days following the initiation of MV support |
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