Interprofessional ApproachNCT06825299
Interprofessional Approach to Ultrasound Diagnosis and Intervention in Critical Care Patients With Pneumothorax and/or Hemothorax
A study testing Chest-Tube Insertion in people with Interprofessional Approach and Ultrasound, run by Tanta University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Interprofessional Approach, Ultrasound, Intervention
- What is being tested?
- Chest-Tube Insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
.
- Conditions
- Interprofessional Approach, Ultrasound, Intervention, Critical Care, Pneumothorax, Hemothorax
- Being tested
- Chest-Tube Insertion
- Medical subject headings
- Pneumothorax, Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest-Tube InsertionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | 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 Receives: Diagnostic Test: Chest-Tube Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ultrasound diagnosis
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)
Measured: Diagnosis 24 hours
Secondary outcomes (4)
Efficacy of ultrasound in intervention
Efficacy of ultrasound in intervention used (chest tube /pigtail) was recoeded.
Measured: 10 days after intervention
Monitoring team performance
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
Measured: 24 hours after intervention
Duration of insertion
Duration of insertion was recorded
Measured: 30 minutes intervention
Incidence of complications
Incidence of complication were recorded such as infection, bleeding, visceral injury, and visceral injury.
Measured: 72 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Oct 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interprofessional ApproachStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Salama Gaber, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825299
- Sponsor's protocol ID
- 36264MS339/9/23
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06825299
- Acronym / sponsor ID
- 36264MS339/9/23
- Conditions
- Interprofessional Approach, Ultrasound, Intervention, Critical Care, Pneumothorax, Hemothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Diagnostic Test: Chest-Tube InsertionThe 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest-Tube InsertionThe 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. | Diagnostic test | Group I |
Primary outcome
Efficacy of ultrasound diagnosis
Time frame: Diagnosis 24 hours
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)
4 secondary outcomes
Efficacy of ultrasound in intervention
Time frame: 10 days after intervention
Monitoring team performance
Time frame: 24 hours after intervention
Duration of insertion
Time frame: 30 minutes intervention
Incidence of complications
Time frame: 72 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest-Tube Insertion in people with Interprofessional Approach and Ultrasound, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of ultrasound diagnosis (time frame: Diagnosis 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.