Lung Ultrasound as Alternative to Radiography in Thoracic Surgery

NCT06261411 | Active Not Recruiting

• 2 other identifiers: 999430FOU2024-00038
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery. Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs.

Conditions

Thoracic Surgery; Ultrasonography

Keywords

Thoracic surgery; Lung ultrasound; Chest X-ray; Nurse

Outcome Measures

Primary Outcomes (1)

• Reduction in chest x-ray

  Reduction in chest x-ray in patients undergoing thoracic surgery when LUS is the primary method of investigation.

  Through patient hospital stay, an average of five days

Secondary Outcomes (4)

• Re-insertion of chest tube

  Through patient hospital stay, an average of five days

• Delayed removal of chest tube

  Through patient hospital stay, an average of five days

• Time to chest tube removal

  Through patient hospital stay, an average of five days

• Patient Satisfaction

  Through patient hospital stay, an average of five days

Other Outcomes (2)

• Missed Care

  Through patient hospital stay, an average of five days

• Inter-rater variability

  Through patient hospital stay, an average of five days

Study Arms (2)

Lung Ultrasound

EXPERIMENTAL

Lung ultrasound based on specified protocol as primary method of investigation

Diagnostic Test: Lung Ultrasound

Routine Care

NO INTERVENTION

Routine care defined as conventional chest x-ray as primary method of investigation

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

Diagnostic ultrasound of pulmonary tissues such as pleura, plural spaces, and parenchyma.

Also known as: LUS

Lung Ultrasound

Eligibility Criteria

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

You may qualify if:

• Segmental, partial, or wedge resection lung surgery, or lobectomy.
• Written informed consent
• Available research team for measurements.

You may not qualify if:

• Pregnancy
• Re-surgery due to complications related to the original surgery
• Need for critical care or admittance to the ICU.
• Patient or physician choice of withdrawal from the study

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala Akademiska sjukhuset

Uppsala, Uppland, 751 85, Sweden

Location

Study Officials

• Laila Hellgren-Johansson, PhD

  Region Uppsala

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Inter-rater variability will be masked.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Case-Control

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: February 12, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

SE (1)