Ultrasound to Evaluate Failure of Liberation From Mechanical Ventilation

NCT02723565 | Completed

• 1 other identifier: 14-7400-B
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the heart, lungs and diaphragm of patients who fail a trial of spontaneous breathing to determine the physiological mechanism of weaning failure.

Conditions

Acute Respiratory Failure; Respiration, Artificial; Weaning

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity for diagnosis of physiological mechanisms causing weaning failure

  Mechanisms responsible for weaning failure will be diagnosed by field experts using clinical data collected from the chart along with physiological measurements (respiratory mechanics, maximal inspiratory pressure, markers of pulmonary edema including changes in serum total protein and BNP and central venous pressure). The diagnosis derived from a pre-specified ultrasound-based classification system will be compared to the gold standard expert-derived diagnosis.

  Physiological measurements for diagnostic classification measured simultaneously with ultrasound measurements

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

Patients in the intensive care unit.

You may qualify if:

• patients over 18 years of age receiving invasive mechanical ventilation for at least 24 hours
• patients who fulfill standard criteria for readiness for a trial of spontaneous breathing (no or minimal sedation, patient awake and interactive; minimal vasopressor/inotrope requirements (Norepinephrine \< or = 0.1, Dopamine \< 10, Vasopressin/Epinephrine off); fraction of inspired oxygen \< or = 50%; spontaneous inspiratory efforts as indicated by patient-triggered breaths; positive end-expiratory pressure \< or = 10 cm H20)
• patients who fail a trial of spontaneous breathing (transient reduction of ventilator support for any duration up to 2 hours as per local ICU practice - typically PS 5 with PEEP 5 OR CPAP 5 OR T-piece)

You may not qualify if:

• patients with a coagulopathy (INR \> 2.5, platelet count \< 30x10\^6/L) or previously diagnosed bleeding diathesis or are receiving anticoagulant drugs at therapeutic doses (ie. excluding venous thromboembolic prophylaxis)
• patients with a contraindication to nasogastric tube insertion (esophageal varices, upper GI tract surgery, facial trauma, etc.)
• patients receiving extra-corporeal life support

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (3)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Ewan C Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: April 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)