CClinicalTrials.gg
Status unknownNCT01724034WeanUSUpdated Nov 9, 2012

Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients

An interventional study of Abolish Lung Sliding and Normal Lung Ultrasound in Difficult-to-wean Adult Patients, sponsored by Hospital Ernesto Dornelles. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-09.

Sponsored by Hospital Ernesto Dornelles · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Difficult-to-wean Adult Patients

Keywords

  • Weaning
  • Mechanical Ventilation
  • Lung Ultrasound
03

In context

Lead sponsor

Hospital Ernesto Dornelles is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

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

  • No intervention
    Control Group

Interventions

  • OtherAbolish Lung Sliding

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

  • OtherNormal 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.

  • OtherPulmonary 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.

    Also known as: B Lines

  • OtherAsymmetrical Lung Ultrasound

    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

  • OtherSimple 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.

  • OtherComplex Pleural Effusion

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

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Number of tracheostomies performed

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

  2. Length of ICU stay

    Time frame: from icu admition until icu discharge, up to 2 months

  3. Incidence of ventilation-associated pneumonia

    Time frame: until icu discharge, up to 2 months

  4. 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

  5. Performance status at ICU's and Hospital's discharge

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

  6. Correlation between findings from ultrasound and other image techniques

    Time frame: after data collection (1 year) - retrospective review

  7. Duration of Weaning

    Time frame: From first failed spontaneous breathing trial or failed extubation until weaning from mechanical ventilation support, up to 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital Ernesto Dornelles
    Porto Alegre, Rio Grande do Sul 90160-093, Brazil
    • Felippe L Dexheimer Neto, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01724034
Lead sponsor
Hospital Ernesto Dornelles
Collaborators
Hospital Moinhos de Vento, Federal University of Rio Grande do Sul
Responsible party
Felippe Leopoldo Dexheimer Neto (M.D., Hospital Ernesto Dornelles) — Principal investigator
First posted
Nov 9, 2012
Start date
Oct 2012
Primary completion
Dec 2013 (estimated)
Completion
Jun 2014 (estimated)
Last update
Nov 9, 2012

Study contacts

Felippe L Dexheimer Neto, MD
Contact
+555132178668
Felippe L Dexheimer, MD
principal investigator · Hospital Ernesto Dornelles
Cassiano Teixeira, MD, PhD
study chair · Hospital Moinhos de Vento
Paulo R Dalcin, MD, PhD
study director · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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