Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients

Not Applicable

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

• Registration Number: NCT01724034
• Lead Sponsor: Hospital Ernesto Dornelles

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.

Study Timeline

• Study Start: 2012-10
• Status Verified: 2012-11
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Last Update Submitted: 2012-11-06
• Study First Posted: 2012-11-09
• Last Update Posted: 2012-11-09
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily Lung Ultrasound	Normal 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.
Daily Lung Ultrasound	Pulmonary Interstitial Syndrome	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.
Daily Lung Ultrasound	Simple Pleural Effusion	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.
Daily Lung Ultrasound	Abolish Lung Sliding	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.
Daily Lung Ultrasound	Asymmetrical 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.
Daily Lung Ultrasound	Complex Pleural Effusion	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of ventilation-associated pneumonia	until icu discharge, up to 2 months
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
Length of ICU stay	from icu admition 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
Number of tracheostomies performed	patients follow-up will continue until weaning from mechanical support, up to 2 months

Trial Locations

Locations (1)

Hospital Ernesto Dornelles; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil