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

February 8, 2025 updated by: Nader Salama Gaber, Tanta University

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

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ElGharbia
      • Tanta, ElGharbia, Egypt, 31527
        • Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Diagnosis 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of ultrasound in intervention
Time Frame: 10 days after intervention
Efficacy of ultrasound in intervention used (chest tube /pigtail) was recoeded.
10 days after intervention
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
24 hours after intervention
Duration of insertion
Time Frame: 30 minutes intervention
Duration of insertion was recorded
30 minutes intervention
Incidence of complications
Time Frame: 72 hours after intervention
Incidence of complication were recorded such as infection, bleeding, visceral injury, and visceral injury.
72 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

February 8, 2025

First Submitted That Met QC Criteria

February 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 8, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 36264MS339/9/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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