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

This study is currently recruiting participants.
Verified November 2012 by Hospital Ernesto Dornelles
Sponsor:
Collaborators:
Hospital Moinhos de Vento
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Felippe Leopoldo Dexheimer Neto, Hospital Ernesto Dornelles
ClinicalTrials.gov Identifier:
NCT01724034
First received: November 5, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Difficult-to-wean Adult Patients
Other: Abolish Lung Sliding
Other: Normal Lung Ultrasound
Other: Pulmonary Interstitial Syndrome
Other: Asymmetrical Lung Ultrasound
Other: Simple Pleural Effusion
Other: Complex Pleural Effusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Daily Lung Ultrasound Assisting Weaning From Mechanical Ventilation in Difficult-to-wean Adult Patients - a Randomized Trial.

Further study details as provided by Hospital Ernesto Dornelles:

Primary Outcome Measures:
  • Time in mechanical ventilation [ Time Frame: from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of tracheostomies performed [ Time Frame: patients follow-up will continue until weaning from mechanical support, up to 2 months ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: from icu admition until icu discharge, up to 2 months ] [ Designated as safety issue: No ]
  • Incidence of ventilation-associated pneumonia [ Time Frame: until icu discharge, up to 2 months ] [ Designated as safety issue: No ]
  • ICU's, Hospital's and 28-days mortality [ Time Frame: until ICU's and hospital's discharge and 28th day from ICU admisson, with an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • Performance status at ICU's and Hospital's discharge [ Time Frame: at icu's and hospital discharge, with an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • Correlation between findings from ultrasound and other image techniques [ Time Frame: after data collection (1 year) - retrospective review ] [ Designated as safety issue: No ]
  • Duration of Weaning [ Time Frame: From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.
No Intervention: Control Group

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724034

Contacts
Contact: Felippe L Dexheimer Neto, MD +555132178668

Locations
Brazil
Hospital Ernesto Dornelles Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
Principal Investigator: Felippe L Dexheimer Neto, MD         
Sponsors and Collaborators
Hospital Ernesto Dornelles
Hospital Moinhos de Vento
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Felippe L Dexheimer, MD Hospital Ernesto Dornelles
Study Chair: Cassiano Teixeira, MD, PhD Hospital Moinhos de Vento
Study Director: Paulo R Dalcin, MD, PhD Federal University of Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Felippe Leopoldo Dexheimer Neto, M.D., Hospital Ernesto Dornelles
ClinicalTrials.gov Identifier: NCT01724034     History of Changes
Other Study ID Numbers: 094/2011
Study First Received: November 5, 2012
Last Updated: November 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Ernesto Dornelles:
Weaning
Mechanical Ventilation
Lung Ultrasound

ClinicalTrials.gov processed this record on April 17, 2014