Adherence to LPV in SICU and Associated Clinical Outcomes

NCT03698799 | Completed

• 1 other identifier: 077/2561(EC4)
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adult; Guideline Adherence; Humans; Intensive Care Units; Perioperative/Postoperative Complications; Respiration, Artificial; Tidal Volume

Keywords

Adherence; Intensive Care Unit; Lung Protective Strategy; Mechanical Ventilation; Perioperative Critical Care; Surgical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidences of pulmonary and other complications

  During the first 7 consecutive days following the initiation of MV support

• Length of stay in SICU and in hospital

  Up to 90 days following the initiation of MV support

• SICU and hospital discharge status, and status at 28 and 90 days

  Up to 90 days following the initiation of MV support

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (11)

• 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.

  PMID: 24762100 BACKGROUND

• 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.

  PMID: 23709192 BACKGROUND

• 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.

  PMID: 25546532 BACKGROUND

• 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.

  PMID: 23450544 BACKGROUND

• 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.

  PMID: 26955891 BACKGROUND

• 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.

  PMID: 23093163 BACKGROUND

• 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.

  PMID: 26181219 BACKGROUND

• 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.

  PMID: 26017128 RESULT

• 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.

  PMID: 16424706 RESULT

• 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.

  PMID: 18434907 RESULT

• 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.

  PMID: 24569355 RESULT

MeSH Terms

Conditions

Postoperative Complications; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Annop Piriyapatsom, MD

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 9, 2018
• Study Start: April 9, 2018
• Primary Completion: June 30, 2019
• Study Completion: March 20, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)