- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06825299
Interprofessional Approach to Ultrasound Diagnosis and Intervention in Critical Care Patients With Pneumothorax and/or Hemothorax
Interprofessional Approach to Ultrasound Diagnosis and Intervention in Critical Care Patients With Pneumothorax and/or Hemothorax (Steering the Eagerness Towards Standardization of the Third Core Competency in ICU)
Investigate the efficacy of interprofessional team approach to ultrasound guided diagnosis and intervention (pigtail or chest tube insertion) in critical care patients with Pneumothorax and/or hemothorax.
Evaluate the safety of the procedure {Insertion- related complications. Assess the Duration of chest tube insertion
Study Overview
Status
Intervention / Treatment
Detailed Description
Pneumothorax is defined as the presence of air in the pleural cavity; it can be secondary to underlying pulmonary pathology or trauma. In trauma, about 40-50% of thoracic injuries develop pneumothorax. Traditionally, following the suggestion of the American College of Chest Physicians and the Advanced Trauma Life Support (ATLS), all traumatic pneumothoraxes must be treated with a pleural drainage that could be chest tube (CT) or pigtail catheter (PC).
Insertion of pleural drains is a common surgical procedure. Percutaneous pleural drainage is the third most performed procedure in the intensive care unit (ICU) after vascular catheterization and tracheal intubation.
Bedside-ultrasound is introducing the advantage of at-time diagnosis and evaluation of different parameters without the need for risky transport of critical patients outside ICU and also guiding safe and successful intervention without complications and good learning.
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Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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ElGharbia
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Tanta, ElGharbia, Egypt, 31527
- Tanta university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 21 to 65 years
- Both sexes.
- Patients with pneumothorax or hemothorax indicated for chest tube or pig tail insertion according to British Thoracic Society (BTS) June 2022 guidelines for pleural procedures.
Exclusion Criteria:
- Absolute contraindication: patients in which the lung is completely adherent to the chest wall throughout the hemithorax.
- Relative contraindications: patients with risk of bleeding in patients:
- Taking anticoagulant medication.
- Patients with abnormal clotting profiles, coagulopathies, and platelet defects.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group I
The Technique was performed according to combination of the BTS guidelines for chest tube insertion and US-guided technique for chest tube insertion by Dev et al. and Menegozzo et al. and US-guided pigtail insertion by Vetrugno et al
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The technique was performed according to a combination of the Chest-Tube Insertion (BTS) guidelines for chest tube insertion and ultrasound (US)-guided technique for chest tube insertion and US-guided pigtail insertion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Efficacy of ultrasound diagnosis
Time Frame: Diagnosis 24 hours
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Efficacy of ultrasound in intervention by Diagnosis of pneumothorax/hemothorax starting by physical examination followed by bed side ultrasound examination according to the international consensus conference recommendations (international evidence-based recommendations for point-of-care lung ultrasound)
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Diagnosis 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Efficacy of ultrasound in intervention
Time Frame: 10 days after intervention
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Efficacy of ultrasound in intervention used (chest tube /pigtail) was recoeded.
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10 days after intervention
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Monitoring team performance
Time Frame: 24 hours after intervention
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Monitoring team performance: team satisfaction was recorded using a 5-point Likert scale team satisfaction (1, very dissatisfied; 2, dissatisfied; 3, Okey; 4, satisfied; 5, very satisfied) in our study as an item related to team performance
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24 hours after intervention
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Duration of insertion
Time Frame: 30 minutes intervention
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Duration of insertion was recorded
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30 minutes intervention
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Incidence of complications
Time Frame: 72 hours after intervention
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Incidence of complication were recorded such as infection, bleeding, visceral injury, and visceral injury.
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72 hours after intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264MS339/9/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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