USEFUL: Ultrasound to Evaluate Failure of Liberation From Mechanical Ventilation

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02723565

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure Respiration, Artificial Weaning

Detailed Description

The transition to unassisted breathing after invasive ventilation often proves challenging, with over 40% of patients failing their first attempt of unassisted breathing. Persistent ventilator dependence predisposes patients to nosocomial complications and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. Many patients who are dependent on the ventilator also show a striking loss of pump capacity due to diaphragm dysfunction. Though each of these mechanisms respond to specific interventions, it is often difficult for physicians to discern which mechanisms are at play at the bedside. Bedside ultrasound is a potentially useful means of evaluating cardiac, pulmonary and diaphragm function during weaning failure. It is readily available, highly feasible and already widely employed in clinical practice. As yet, no study has evaluated the accuracy and feasibility of combining echocardiography with lung and diaphragm ultrasound to comprehensively evaluate the physiological mechanisms of weaning failure. The objectives of this study are to establish the utility of a rapid thoracic ultrasound exam to diagnose mechanisms of ventilation liberation failure and to assess the relationship between cardiothoracic variability during spontaneous breathing and different physiological mechanism of weaning failure.

Study Design

Study Type:

Observational

Actual Enrollment :

7 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ultrasound to Evaluate Failure of Liberation From Mechanical Ventilation

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity for diagnosis of physiological mechanisms causing weaning failure [Physiological measurements for diagnostic classification measured simultaneously with ultrasound measurements]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
2	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5
3	University Health Network	Toronto	Ontario	Canada	M5G 2N2

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Ewan C Goligher, MD, PhD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ewan Goligher, Intensivist, University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT02723565

Other Study ID Numbers:

14-7400-B

First Posted:

Mar 30, 2016

Last Update Posted:

Mar 28, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Mar 28, 2019