Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients

Difficult-to-wean Adult Patients Clinical Trial

— WeanUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01724034
• Other study ID #: 094/2011
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 6, 2012
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2012
• Source: Hospital Ernesto Dornelles
• Contact: Felippe L Dexheimer Neto, MD
• Phone: +555132178668
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Difficult-to-wean Adult Patients

Intervention

Other:
• Abolish Lung Sliding
If there is no lung sliding, the patient will be promptly evaluated for pneumothorax or mainstream intubation.
• 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.
• 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.
• Asymmetrical Lung Ultrasound
If lung ultrasound shows asymmetrical findings, the occurence of new or uncontrolled infection (pulmonary or extrapulmonary) will be investigated.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Ernesto Dornelles	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Ernesto Dornelles	Federal University of Rio Grande do Sul, Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in mechanical ventilation		from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days)	No
Secondary	Number of tracheostomies performed		patients follow-up will continue until weaning from mechanical support, up to 2 months	No
Secondary	Length of ICU stay		from icu admition until icu discharge, up to 2 months	No
Secondary	Incidence of ventilation-associated pneumonia		until icu discharge, up to 2 months	No
Secondary	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	No
Secondary	Performance status at ICU's and Hospital's discharge		at icu's and hospital discharge, with an expected average of 4 weeks	No
Secondary	Correlation between findings from ultrasound and other image techniques		after data collection (1 year) - retrospective review	No
Secondary	Duration of Weaning		From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks	No