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Completed

NCT Number: NCT06825299

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

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

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Key information

Conditions

Interprofessional Approach Critical Care Hemorrhage Hemothorax Intervention Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pneumothorax Respiratory Tract Diseases Ultrasound

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, ElGharbia, 31527, Egypt

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chest-Tube Insertion

Diagnostic 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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Efficacy of ultrasound in intervention

    Time frame: 10 days after intervention

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

  2. Monitoring team performance

    Time frame: 24 hours after intervention

    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

  3. Duration of insertion

    Time frame: 30 minutes intervention

    Duration of insertion was recorded

  4. Incidence of complications

    Time frame: 72 hours after intervention

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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