Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients

NCT01724034 | Unknown

• 1 other identifier: 094/2011
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult-to-wean Adult Patients

Keywords

Weaning; Mechanical Ventilation; Lung Ultrasound

Outcome Measures

Primary Outcomes (1)

• Time in mechanical ventilation

  from intubation until extubation success (defined as weaning from mechanical support for, at least, 48 hours) or death (days)

Secondary Outcomes (7)

• Number of tracheostomies performed

  patients follow-up will continue until weaning from mechanical support, up to 2 months

• Length of ICU stay

  from icu admition until icu discharge, up to 2 months

• Incidence of ventilation-associated pneumonia

  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

• Performance status at ICU's and Hospital's discharge

  at icu's and hospital discharge, with an expected average of 4 weeks

Study Arms (2)

Daily Lung Ultrasound

EXPERIMENTAL

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; Other: Normal Lung Ultrasound; Other: Pulmonary Interstitial Syndrome; Other: Asymmetrical Lung Ultrasound; Other: Simple Pleural Effusion; Other: Complex Pleural Effusion

Control Group

NO INTERVENTION

Interventions

Abolish Lung Sliding OTHER

If there is no lung sliding, the patient will be promptly evaluated for pneumothorax or mainstream intubation.

Daily Lung Ultrasound

Normal Lung Ultrasound OTHER

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.

Daily Lung Ultrasound

Pulmonary Interstitial Syndrome OTHER

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.

Also known as: B Lines

Daily Lung Ultrasound

Asymmetrical Lung Ultrasound OTHER

If lung ultrasound shows asymmetrical findings, the occurence of new or uncontrolled infection (pulmonary or extrapulmonary) will be investigated.

Also known as: AB Profile or Consolidation

Daily Lung Ultrasound

Simple Pleural Effusion OTHER

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.

Daily Lung Ultrasound

Complex Pleural Effusion OTHER

If there is pleural effusion with hyperechoic or septated pattern, another image exam will be performed and evaluated by the surgical team.

Daily Lung Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Difficult to Wean;
• failure in the spontaneous breathing trial or 1 extubation failure
• Adult patients (over 18 years old);

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Ernesto Dornelles: lead
• Hospital Moinhos de Vento: collaborator
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

RECRUITING

Study Officials

• Felippe L Dexheimer, MD

  Hospital Ernesto Dornelles

  PRINCIPAL INVESTIGATOR

• Cassiano Teixeira, MD, PhD

  Hospital Moinhos de Vento

  STUDY CHAIR

• Paulo R Dalcin, MD, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Felippe L Dexheimer Neto, MD

CONTACT

+555132178668

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 9, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

BR (1)