Adherence to LPV in SICU and Associated Clinical Outcomes

NCT ID: NCT03698799

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 306 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2020-03-20

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.

Detailed Description

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Non-LPV

Patients do not receive LPV strategy at the initiation of MV support.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Annop Piriyapatsom, MD

Lecturer, Department of Anesthesiology, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annop Piriyapatsom, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 24762100 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23709192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25546532 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23450544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26955891 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23093163 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26181219 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26017128 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16424706 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18434907 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24569355 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

077/2561(EC4)

Identifier Type: -

Identifier Source: org_study_id