Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients (WeanUS)
|ClinicalTrials.gov Identifier: NCT01724034|
Recruitment Status : Unknown
Verified November 2012 by Felippe Leopoldo Dexheimer Neto, Hospital Ernesto Dornelles.
Recruitment status was: Recruiting
First Posted : November 9, 2012
Last Update Posted : November 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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.|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||June 2014|
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 LinesOther: 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 ConsolidationOther: 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|
- 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) ]
- Number of tracheostomies performed [ Time Frame: patients follow-up will continue until weaning from mechanical support, up to 2 months ]
- Length of ICU stay [ Time Frame: from icu admition until icu discharge, up to 2 months ]
- Incidence of ventilation-associated pneumonia [ Time Frame: until icu discharge, up to 2 months ]
- 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 ]
- Performance status at ICU's and Hospital's discharge [ Time Frame: at icu's and hospital discharge, with an expected average of 4 weeks ]
- Correlation between findings from ultrasound and other image techniques [ Time Frame: after data collection (1 year) - retrospective review ]
- Duration of Weaning [ Time Frame: From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724034
|Contact: Felippe L Dexheimer Neto, MD||+555132178668|
|Hospital Ernesto Dornelles||Recruiting|
|Porto Alegre, Rio Grande do Sul, Brazil, 90160-093|
|Principal Investigator: Felippe L Dexheimer Neto, MD|
|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|