Respiratory Mechanics Registry for ARDS Patients

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Respiratory Mechanics in Acute Respiratory Distress Syndrome: A Quality Improvement-based Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02623192
• Other study ID #: REB# 15-098
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2015
• Last updated: July 24, 2017
• Start date: August 2014
• Est. completion date: August 2018

Study information

• Verified date: July 2017
• Source: St. Michael's Hospital, Toronto
• Contact: Laurent Brochard, MD
• Phone: 416-864-5686
• Email: BrochardL[@]smh.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry was proposed to investigate the epidemiology of respiratory mechanics in patients with ARDS through collecting data from a QI project which was constituted with systematic assessments of respiratory mechanics and gas exchange.

Description:

The amount of respiratory impairment in patients with Acute Respiratory Distress Syndrome (ARDS) is variable and applying the same ventilator regimen to every patient is questionable. In order to individualize ventilator management, monitoring respiratory mechanics may help to decide ventilator settings or set limits. A systematic assessment of respiratory mechanics and gas exchange response in patients who meet the criteria for ARDS has been initiated as a Quality Improvement (QI) project in the Department of Critical Care at St. Michael's Hospital. The QI project aims to facilitate the use of these parameters for ventilatory management. Measurements include: respiratory system, lung and chest wall mechanics (elastance and resistance), oxygenation response to positive end-expiratory pressure (PEEP), and estimate of alveolar recruitability using a simplified bedside maneuver[1]. Placement of an esophageal catheter is considered when the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤200 mmHg[2]. Audits are performed to see whether the measurements influence ventilatory management. Collecting these data into a registry will elicit helpful epidemiological information since the current epidemiological knowledge surrounding respiratory mechanics abnormalities in ARDS is limited. A registry with a large sample size may inform future recommendations. The investigators therefore propose to introduce the collected data from our QI program into an ARDS registry. Similar data obtained from other centers may also contribute to the registry in the future. The primary objective of the registry will be to investigate the epidemiology of abnormal respiratory mechanics in patients with ARDS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients admitted to the Medical-Surgical ICU, Trauma-Neuro ICU, and Cardiovascular ICU who meet the Berlin definition of ARDS and receive invasive ventilation.

Exclusion Criteria:

• Severe hemodynamic instability: > 30% variation of mean arterial pressure and/or heart rate (HR) in the last 2 hours or the need for a high dose of vasopressors (higher than 0.5 µg/kg/min of norepinephrine);

• Patients who present with a known esophageal problem, active upper gastrointestinal bleeding, or any other contraindication for the insertion of a gastric tube.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• Patients who have performed the ARDS pulmonary function test

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Italy	Catholic University of the Sacred Heart	Rome	Lazio

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Beijing Tiantan Hospital, University Hospital, Angers

Countries where clinical trial is conducted

Canada,  Italy, 

References & Publications (2)

Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guérin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI. Review. — View Citation

Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving pressure (centimetre of water)	Epidemiology of physiological abnormalities in respiratory mechanics were be reported.	One hour
Secondary	Transpulmonary pressure (centimetre of water)		One hour
Secondary	Respiratory compliance (millilitre / centimetre of water)		One hour
Secondary	Lung compliance (millilitre / centimetre of water)		One hour