Airway Pressure Release Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome

NCT04156438 | Completed

• 1 other identifier: REB-19-51
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the feasibility of a large clinical trial investigating the effectiveness of airway pressure release ventilation and low tidal volume ventilation for patients with moderate-to-severe acute respiratory distress syndrome.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Airway pressure release ventilation; low tidal volume ventilation; APRV; ARDSNet ventilation; LTVV; acute respiratory distress syndrome; ARDS

Outcome Measures

Primary Outcomes (3)

• Informed consent rate

  A successful informed consent rate will be defined as ≥70% of substitute decision makers or patients approached choosing to participate in this trial

  Informed consent rate will be measured over a 1 year period of the pilot study

• Recruitment rate

  A successful recruitment rate will be achieving at least 15 patients over the 1 year period.

  Recruitment rate will be measured over the one year of the pilot study.

• Protocol adherence rate

  An adherence rate of at least 80% will be considered successful.

  Protocol adherence will be measured for each study patient, and compiled over the duration of the pilot study (i.e. 1 year).

Secondary Outcomes (6)

• 28-day mortality

  Up to Day 28

• In-hospital mortality

  Up to 365 days

• ICU length of stay

  Up to 365 days

• Hospital length of stay

  Up to 365 days

• Length/duration of mechanical ventilation

  Up to 365 days

Study Arms (2)

Low tidal volume ventilation

ACTIVE COMPARATOR

Conventional low tidal volume ventilation

Device: Low tidal volume ventilation

Airway pressure release ventilation

EXPERIMENTAL

Early use of airway pressure release ventilation

Device: Airway pressure release ventilation

Interventions

Low tidal volume ventilation DEVICE

Conventional ventilation strategy for patient with ARDS

Low tidal volume ventilation

Airway pressure release ventilation DEVICE

Experimental ventilation protocol for patients with ARDS

Airway pressure release ventilation

Eligibility Criteria

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

You may qualify if:

• Fulfilling the diagnostic criteria of ARDS, according to the Berlin definition
• Moderate to severe ARDS as defined as a PaO2: FiO2 ratio of ≤150 during invasive mechanical ventilation
• Endotracheal intubation and mechanical ventilation for ARDS less than 48 hours

You may not qualify if:

• Age less than 18 years
• Pregnancy
• Intracranial hypertension (suspected or confirmed)
• Severe chronic obstructive pulmonary disease as defined by either:
• FEV1/FVC less than 50% predicted, or
• Chronic hypercarbia (PaCO2\>45 mmHg), chronic hypoxemia (PaO2 \< 55 mmHg) on room air, and/or elevated admission serum HCO3 \>30 mmol/L
• Presence of documented barotrauma, i.e. pneumothorax
• Treatment with extracorporeal support (ECMO) at enrollment
• Refractory shock
• Advanced directives indicating preferences to not have advanced life support
• Moribund patient, i.e. not expected to survive longer than 24 hours

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead

Study Sites (1)

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

Related Publications (18)

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 BACKGROUND

• Walkey AJ, Summer R, Ho V, Alkana P. Acute respiratory distress syndrome: epidemiology and management approaches. Clin Epidemiol. 2012;4:159-69. doi: 10.2147/CLEP.S28800. Epub 2012 Jul 16.

  PMID: 22866017 BACKGROUND

• Gattinoni L, Pesenti A. The concept of "baby lung". Intensive Care Med. 2005 Jun;31(6):776-84. doi: 10.1007/s00134-005-2627-z. Epub 2005 Apr 6.

  PMID: 15812622 BACKGROUND

• de Haro C, Martin-Loeches I, Torrents E, Artigas A. Acute respiratory distress syndrome: prevention and early recognition. Ann Intensive Care. 2013 Apr 24;3(1):11. doi: 10.1186/2110-5820-3-11.

  PMID: 23617961 BACKGROUND

• Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

  PMID: 10793162 BACKGROUND

• Ferguson ND, Cook DJ, Guyatt GH, Mehta S, Hand L, Austin P, Zhou Q, Matte A, Walter SD, Lamontagne F, Granton JT, Arabi YM, Arroliga AC, Stewart TE, Slutsky AS, Meade MO; OSCILLATE Trial Investigators; Canadian Critical Care Trials Group. High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med. 2013 Feb 28;368(9):795-805. doi: 10.1056/NEJMoa1215554. Epub 2013 Jan 22.

  PMID: 23339639 BACKGROUND

• Young D, Lamb SE, Shah S, MacKenzie I, Tunnicliffe W, Lall R, Rowan K, Cuthbertson BH; OSCAR Study Group. High-frequency oscillation for acute respiratory distress syndrome. N Engl J Med. 2013 Feb 28;368(9):806-13. doi: 10.1056/NEJMoa1215716. Epub 2013 Jan 22.

  PMID: 23339638 BACKGROUND

• Jain SV, Kollisch-Singule M, Sadowitz B, Dombert L, Satalin J, Andrews P, Gatto LA, Nieman GF, Habashi NM. The 30-year evolution of airway pressure release ventilation (APRV). Intensive Care Med Exp. 2016 Dec;4(1):11. doi: 10.1186/s40635-016-0085-2. Epub 2016 May 20.

  PMID: 27207149 BACKGROUND

• Andrews PL, Shiber JR, Jaruga-Killeen E, Roy S, Sadowitz B, O'Toole RV, Gatto LA, Nieman GF, Scalea T, Habashi NM. Early application of airway pressure release ventilation may reduce mortality in high-risk trauma patients: a systematic review of observational trauma ARDS literature. J Trauma Acute Care Surg. 2013 Oct;75(4):635-41. doi: 10.1097/TA.0b013e31829d3504.

  PMID: 24064877 BACKGROUND

• Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

  PMID: 23902482 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

• Maxwell RA, Green JM, Waldrop J, Dart BW, Smith PW, Brooks D, Lewis PL, Barker DE. A randomized prospective trial of airway pressure release ventilation and low tidal volume ventilation in adult trauma patients with acute respiratory failure. J Trauma. 2010 Sep;69(3):501-10; discussion 511. doi: 10.1097/TA.0b013e3181e75961.

  PMID: 20838119 BACKGROUND

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

• Habashi NM. Other approaches to open-lung ventilation: airway pressure release ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S228-40. doi: 10.1097/01.ccm.0000155920.11893.37.

  PMID: 15753733 BACKGROUND

• Lim J, Litton E, Robinson H, Das Gupta M. Characteristics and outcomes of patients treated with airway pressure release ventilation for acute respiratory distress syndrome: A retrospective observational study. J Crit Care. 2016 Aug;34:154-9. doi: 10.1016/j.jcrc.2016.03.002. Epub 2016 Mar 9.

  PMID: 27020770 BACKGROUND

• Sydow M, Burchardi H, Ephraim E, Zielmann S, Crozier TA. Long-term effects of two different ventilatory modes on oxygenation in acute lung injury. Comparison of airway pressure release ventilation and volume-controlled inverse ratio ventilation. Am J Respir Crit Care Med. 1994 Jun;149(6):1550-6. doi: 10.1164/ajrccm.149.6.8004312.

  PMID: 8004312 BACKGROUND

• Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.

  PMID: 28936695 BACKGROUND

• Seal K, Featherstone R. Airway Pressure Release Ventilation for Acute Respiratory Distress Syndrome: Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Feb 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK531787/

  PMID: 30307725 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Eric J Sy, MD MPH FRCPC

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Physician

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: November 7, 2019
• Study Start: June 29, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)