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

NCT06825299 | Completed

• 1 other identifier: 36264MS339/9/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Interprofessional Approach; Ultrasound; Intervention; Critical Care; Pneumothorax; Hemothorax

Outcome Measures

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)

  Diagnosis 24 hours

Secondary Outcomes (4)

• Efficacy of ultrasound in intervention

  10 days after intervention

• Monitoring team performance

  24 hours after intervention

• Duration of insertion

  30 minutes intervention

• Incidence of complications

  72 hours after intervention

Study Arms (1)

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

Diagnostic Test: Chest-Tube Insertion

Interventions

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.

Group I

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pneumothorax; Hemothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine,Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: October 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

EG (1)