Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients (WeanUS)

Daily Lung Ultrasound Assisting Weaning From Mechanical Ventilation in Difficult-to-wean Adult Patients - a Randomized Trial.

Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean adult patients. In this randomized trial, standardized lung ultrasound will be performed daily asssociated with standardized interventions aiming to decrease the total time in mechanical ventilation.

Study Overview

• Status: Unknown
• Conditions: Difficult-to-wean Adult Patients
• Intervention / Treatment: Other: Abolish Lung Sliding; Other: Normal Lung Ultrasound; Other: Pulmonary Interstitial Syndrome; Other: Asymmetrical Lung Ultrasound; Other: Simple Pleural Effusion; Other: Complex Pleural Effusion

Detailed Description

This trial will be performed in two intensive care units (ICUs). After randomization, all patients in the intervention group will undergo daily lung ultrasounds before the next spontaneous breathing trial. The results from the lung ultrasound will indicate specific interventions to facilitate weaning:

• No sign of lung sliding (ultrasound finding suggestive of pleural movement): prompt evaluation for pneumothorax or mainstream intubation will be indicated;
• normal lung ultrasound (ultrasound A profile): the patient will be evaluated for deep vein thrombosis / pulmonary embolism and/or for reversible airway obstruction (e.g. uncontrolled asthma or COPD [Chronic Obstructive Pulmonary Disease] exacerbation)- followed by appropriate treatment. If the patient has COPD, non invasive mechanical ventilation must be used as mode of discontinuing mechanical ventilation;
• lung ultrasound shows pulmonary edema (ultrasound B profile): cardiogenic pulmonary edema will be differentiated from acute Respiratory Distress Syndrome (ARDS) - followed by appropriate treatment (e.g. a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial);
• lung ultrasound shows asymmetrical patterns (ultrasound AB profile or Pulmonary Consolidation): the possibility of an uncontrolled infection will be investigated;
• presence of simple pleural effusion: diuretics will be indicated (for a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial) or thoracocentesis at description of the assistant team;
• presence of complex pleural effusion: other image exam will be performed, and will be evaluated by the surgical team.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
      • Recruiting
      • Hospital Ernesto Dornelles
      • Principal Investigator: Felippe L Dexheimer Neto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Difficult to Wean;
• 1 failure in the spontaneous breathing trial or 1 extubation failure
• Adult patients (over 18 years old);

Exclusion Criteria:

• Palliative Care;
• Life expectancy under 90 days;
• COPD Gold IV, Cirrhosis Child C, Metastatic Cancer with low performance, etc
• Other weaning method than institutional protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Daily Lung Ultrasound; If there is no lung sliding - evaluation for pneumothorax or mainstream intubation. If lung ultrasound shows normal pattern - search for reversible airway obstruction or venous embolism. If the patient has COPD, non invasive ventilation must be used as mode of discontinuing mechanical ventilation. If lung ultrasound shows intersticial syndrome - evaluate the need to negativate hydric balance before the next spontaneous breathing trial. If findings are asymmetrical - search for new or uncontrolled infection. If there is simple pleural effusion - researchers should determine a negativation of hydric balance or perform thoracocentesis. If there are signs of complicated pleural effusion - a new image technique should be performed as evaluated by the surgical team.	Other: Abolish Lung Sliding; If there is no lung sliding, the patient will be promptly evaluated for pneumothorax or mainstream intubation.; Other: Normal Lung Ultrasound; If the patient fails the spontaneous breathing trial and the lung ultrasound examination is normal - researchers will investigate venous thrombosis (deep vein thrombosis and/or pulmonary embolism) and rule out reversible airway obstruction. If the patient has the previous diagnosis of COPD, non invasive mechanical ventilation is indicated for facilitate weaning.; Other: Pulmonary Interstitial Syndrome; If lung ultrasound shows "B pattern" - cardiogenic pulmonary edema will be differentiated from Acute Respiratory Distress Syndrome (ARDS). If cardiogenic edema is a possibility, diuretics will be administrated (at least 40 mg of furosemide) or ultrafiltration will be performed. The main target is a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to titrate vasodilators (at least a 20% reduction in the systolic blood pressure) before the next spontaneous breathing trial.; Other Names: B Lines; Other: Asymmetrical Lung Ultrasound; If lung ultrasound shows asymmetrical findings, the occurence of new or uncontrolled infection (pulmonary or extrapulmonary) will be investigated.; Other Names: AB Profile or Consolidation; Other: Simple Pleural Effusion; If the patient has pleural effusion without ultrasonographic signs of complications (any hyperechoic pattern or complex septated pattern), researchers will administrate diuretics (at least 40 mg of furosemide in 24 hours) or increase ultrafiltration - to achieve a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to perform pleural drainage.; Other: Complex Pleural Effusion; If there is pleural effusion with hyperechoic or septated pattern, another image exam will be performed and evaluated by the surgical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time in mechanical ventilation	from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of tracheostomies performed	patients follow-up will continue until weaning from mechanical support, up to 2 months
Length of ICU stay	from icu admition until icu discharge, up to 2 months
Incidence of ventilation-associated pneumonia	until icu discharge, up to 2 months
ICU's, Hospital's and 28-days mortality	until ICU's and hospital's discharge and 28th day from ICU admisson, with an expected average of 4 weeks
Performance status at ICU's and Hospital's discharge	at icu's and hospital discharge, with an expected average of 4 weeks
Correlation between findings from ultrasound and other image techniques	after data collection (1 year) - retrospective review
Duration of Weaning	From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks

Collaborators and Investigators

• Sponsor: Hospital Ernesto Dornelles
• Collaborators: Federal University of Rio Grande do Sul; Hospital Moinhos de Vento
• Investigators: Study Chair: Cassiano Teixeira, MD, PhD, Hospital Moinhos de Vento; Principal Investigator: Felippe L Dexheimer, MD, Hospital Ernesto Dornelles; Study Director: Paulo R Dalcin, MD, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimate): November 9, 2012

Study Record Updates

• Last Update Posted (Estimate): November 9, 2012
• Last Update Submitted That Met QC Criteria: November 6, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Weaning; Mechanical Ventilation; Lung Ultrasound
• Other Study ID Numbers: 094/2011