ClinicalTrials.gg
CompletedNCT06825299Updated Feb 13, 2025

Interprofessional Approach to Ultrasound Diagnosis and Intervention in Critical Care Patients With Pneumothorax and/or Hemothorax

An interventional study of Chest-Tube Insertion in Interprofessional Approach, Ultrasound and Intervention, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Oct 2023, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
21 Years to 65 Years
Sex
All
01

Study 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 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.

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02

Conditions studied

  • Interprofessional Approach
  • Ultrasound
  • Intervention
  • Critical Care
  • Pneumothorax
  • Hemothorax
03

In context

Pneumothorax

183 studies on the registry are indexed under Pneumothorax; 41 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 111 interventional studies indexed under Pneumothorax.

Browse Pneumothorax studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Absolute : 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 defects.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

    Diagnostic Test: Chest-Tube Insertion

Interventions

  • Diagnostic testChest-Tube Insertion

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Diagnosis 24 hours

Secondary outcomes

  1. Efficacy of ultrasound in intervention

    Efficacy of ultrasound in intervention used (chest tube /pigtail) was recoeded.

    Time frame: 10 days after intervention

  2. 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

    Time frame: 24 hours after intervention

  3. Duration of insertion

    Duration of insertion was recorded

    Time frame: 30 minutes intervention

  4. Incidence of complications

    Incidence of complication were recorded such as infection, bleeding, visceral injury, and visceral injury.

    Time frame: 72 hours after intervention

07

Study locations

1 site
  • Tanta University
    Tanta, ElGharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06825299
Lead sponsor
Tanta University
Responsible party
Nader Salama Gaber (Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine,Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Feb 13, 2025
Start date
Oct 1, 2023
Primary completion
Nov 1, 2024
Completion
Nov 1, 2024
Last update
Feb 13, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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