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Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT03880864
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Randa Ali Shoukry, Ain Shams University

Tracking Information
First Submitted Date  ICMJE March 17, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE March 7, 2019
Estimated Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
Successful weaning [ Time Frame: 48 hours ]
patients who will not need re-intubation within after extubation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation
Official Title  ICMJE Application of Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation
Brief Summary Lung aeration loss can be measured via lung ultrasound, it is a non-invasive, bed side procedure, which can be performed rapidly and facilitates a dynamic assessment of lung aeration. Aim of the work: is to determine the role of lung ultrasound score as one of the predictors of successful weaning from mechanical ventilation in ICU patients.
Detailed Description

Patients should be assessed daily for their readiness to be weaned from mechanical ventilation, sedation must be withdrawn and all patients will be put on a spontaneous breathing trial (SBT), via T-piece, for 60 -120 minutes period, when they fulfil the weaning criteria. Patients who succeed to tolerate SBT will be extubated and monitored for signs of respiratory distress.

Clinical assessment during and after SBT:

  • The ability of maintaining a respiration rate of less than 35/min, and keeping oxygen saturation more than 90%.
  • Arterial blood gases (ABGs) will be done 30-60 minutes after SBT and after extubation.
  • To detect signs of respiratory distress: diaphoresis, tachypnea (RR> 35/min), increase activity of accessory muscles of respiration, tachycardia (heart rate > 140 beats per minute), systolic blood pressure > 180 mmHg or <90 mmHg, appearance of new arrhythmia, or alteration in mental status (drowsiness or anxiety). ABGs: PaO2 ≤ 60 mmHg or oxygen saturation < 90% on FiO2 ≥ 0.4, PaCO2 > 50 mmHg, or an increase in by ≥ 8 mmHg, pH < 7.32 or a decrease in pH by ≥ 0.07 pH units.

Clinical assessment will be done by an intensivist who will be blinded to the LUS score results.

Lung ultrasound (LUS): will be performed while patients in supine position, with a curved probe on B- mode, using longitudinal view, to assess the amount of lung aeration. Each lung will be divided into anterior, lateral and posterior regions, each part will be divided to upper and lower zone, with total of 12 zones to undergo examination. Examination will be done by an expert physician in US.

Lung US score [9]: The 12 scanned regions will be summed to calculate the LUS score, which ranged from 0 and 36. In each zone, the worst ultrasound form will considered to be descriptive of the entire region.

  • Score of 0: Normal aeration is signified by the presence of horizontal A lines, lung sliding, or less than 3 vertical B lines.
  • Score of 1: moderate loss of aeration is characterized by multiple regularly or irregularly spaced B lines that originated from the pleural line.
  • Score of 2: Severe loss of aeration is manifested by multiple coalescent B lines in several intercostal spaces of the specific zone. Detected in alveolar-interstitial syndrome.[
  • Score of 3: Complete loss of aeration, as detected in lung consolidation or atelectasis, is characterized by tissue echogenicity, which is similar to liver or splenic tissues.

The score will be performed before starting and at the end of SBT (before extubation), or on developing respiratory distress during SBT.

Patients will be classified according to the possible outcome:

Successful weaning: patients who will not need re-intubation within 48 hours after extubation.

SBT failure: which will be diagnosed by the appearance of signs of respiratory distress during SBT and patients will be connected again to the ventilator. Extubation failure: will be defined as patients who developed signs of respiratory distress after extubation within 48hs and need reintubation or non-invasive ventilatory support.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Weaning Failure
Intervention  ICMJE Radiation: Ultrasound
Lung ultrasound
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2, 2019
Estimated Primary Completion Date July 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

50 adult patients over 18 years, mechanically ventilated via an endotracheal tube for more than 24 hours, whom will have an improvement in the underlying cause of respiratory failure. Fluid balance will be recorded for 48hours before start of weaning and any cardiac dysfunction detected by Echocardiogram will be documented.

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Exclusion Criteria:

patients with tracheostomy, spinal cord injury above than T8; arrhythmias and or haemodynamic instability; patients having pneumothorax, or pneumomediastinum, chest tube or chest injuries, after thoracostomy, and pleural lesions or pleurodesis, also patients having severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume less than 50% of predictive value will also be excluded.

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Randa A Shoukry 002-01001404426 randa_shoukry@hotmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880864
Other Study ID Numbers  ICMJE FMASU R 12/2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Randa Ali Shoukry, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP