Clinical trial NCT01724034: Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients
Official title: Daily Lung Ultrasound Assisting Weaning From Mechanical Ventilation in Difficult-to-wean Adult Patients - a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult-to-wean Adult Patients
Keywords: Weaning
Mechanical Ventilation
Lung Ultrasound
Lead sponsor: Hospital Ernesto Dornelles
Sponsor class: OTHER
Collaborators: name: Hospital Moinhos de Vento
name: Federal University of Rio Grande do Sul
First posted: 2012-11-09
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Time in mechanical ventilation
timeFrame: from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days)
Secondary outcomes:
measure: Number of tracheostomies performed
timeFrame: patients follow-up will continue until weaning from mechanical support, up to 2 months
measure: Length of ICU stay
timeFrame: from icu admition until icu discharge, up to 2 months
measure: Incidence of ventilation-associated pneumonia
timeFrame: until icu discharge, up to 2 months
measure: ICU's, Hospital's and 28-days mortality
timeFrame: until ICU's and hospital's discharge and 28th day from ICU admisson, with an expected average of 4 weeks
measure: Performance status at ICU's and Hospital's discharge
timeFrame: at icu's and hospital discharge, with an expected average of 4 weeks
measure: Correlation between findings from ultrasound and other image techniques
timeFrame: after data collection (1 year) - retrospective review
measure: Duration of Weaning
timeFrame: From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: Rio Grande do Sul
Study officials:
affiliation: Hospital Ernesto Dornelles
name: Felippe L Dexheimer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Cassiano Teixeira, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Paulo R Dalcin, MD, PhD
role: STUDY_DIRECTOR
References: