Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880864
Recruitment Status : Unknown
Verified December 2019 by Randa Ali Shoukry, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : March 19, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Randa Ali Shoukry, Ain Shams University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Weaning Failure Radiation: Ultrasound Phase 1

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Patients should be assessed daily for their readiness to be weaned from mechanical ventilation, sedation must be withdrawn and all patients will be put on a spontaneous breathing trial (SBT), via T-piece, for 60 -120 minutes period, when they fulfil the weaning criteria.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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Application of Lung Ultrasound for Predicting Outcome of Weaning From Mechanical Ventilation
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : December 2, 2019
Estimated Study Completion Date : January 2, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Radiation: Ultrasound
    Lung ultrasound

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients with lung ultrasound score of less than 13 [ Time Frame: 48 hours ]
    Successful weaning: patients who will not need re-intubation within 48 hours after extubation.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50 adult patients over 18 years.
  • Mechanically ventilated via an endotracheal tube for more than 24 hours.
  • Patients that have an improvement in the underlying cause of respiratory failure.

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.
  • Patients having severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume less than 50% of predictive value.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880864


Contacts
Layout table for location contacts
Contact: Randa A Shoukry 002-01001404426 randa_shoukry@hotmail.com

Locations
Layout table for location information
Egypt
Randa Ali Shoukry Recruiting
Cairo, Al-Nozha, Egypt, 11843
Contact: Randa A Shoukry    1001404426    randa_shoukry@hotmail.com   
Randa Ali Shoukry Recruiting
Cairo, Al-Nozha, Egypt, 11843
Contact: Randa A Shoukry    01001404426    randa_shoukry@hotmail.com   
Sponsors and Collaborators
Ain Shams University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Randa Ali Shoukry, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03880864    
Other Study ID Numbers: FMASU R 12/2019
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Randa Ali Shoukry, Ain Shams University:
Lung ultrasound score
Weaning
Mechanical ventilation