LUS to Assess Lung Injury After Lung Lobectomy

NCT04755478 | Unknown

• 1 other identifier: OPEN THORUS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess whether lung ultrasound is able to detect lung injury after lung resection surgery.

Conditions

Lung Neoplasm; Adult ALL; Lung Injury; Lung Inflammation; Lung Ischemia/Hypoxia; Postoperative Complications; Postoperative Respiratory Complication; Lung Cancer; Thoracic

Keywords

thoracic surgery; lung ultrasound; cytokines blood; lung injury; postoperative complications

Outcome Measures

Primary Outcomes (1)

• Change in mLUSS after lung resection.

  The modified lung ultrasound score (mLUSS) ranges 0-36; the higher the score, the less aeration (worse).

  preoperative vs immediate postoperative period vs 24 hours after surgery.

Secondary Outcomes (6)

• LUS feasibility in the dependent and non-dependent lung.

  Preoperative vs immediate postoperative period vs 24 hours after surgery.

• Changes in oxygenation (PAFI) after lung resection.

  Preoperative vs immediate postoperative vs 24 hours after surgery.

• Changes in plasma cytokine IL-6 after lung resection.

  Preoperative vs immediate postoperative vs 24 hours after surgery.

• Changes in plasma cytokine IL-10 after lung resection.

  Preoperative vs immediate postoperative vs 24 hours after surgery.

• Changes in plasma TNFα after lung resection.

  Preoperative vs immediate postoperative vs 24 hours after surgery.

Study Arms (2)

Lung lobectomy via open thoracotomy

participants scheduled for lung lobectomy via open thoracotomy

Procedure: Thoracotomy

Lung lobectomy via VATS

participants scheduled for lung lobectomy via video-assisted thoracoscopic surgery

Procedure: VATS

Interventions

Thoracotomy PROCEDURE

Participants will undergo lobectomy via open thoracotomy at the discretion of the surgical team.

Lung lobectomy via open thoracotomy

VATS PROCEDURE

Participants will undergo lobectomy via VATS at the discretion of the surgical team.

Lung lobectomy via VATS

Eligibility Criteria

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

Study Population

patients assigned to a tertiary referral hospital

You may qualify if:

• Age \> 18
• ASA I-III
• Non-small cell lung neoplasm
• Elective lung lobectomy
• Under one-lung ventilation

You may not qualify if:

• Pregnancy
• Respiratory tract infection the previous month
• Diagnosed pulmonary fibrosis
• Predicted FEV \< 40%
• Surgery that includes resection of the thoracic wall or the diaphragm
• Neoplasm metastasis
• Obesity class II or more (BMI ≥ 35 kg/m\^2)
• Risk of malnutrition CONUT \> 1
• Hemoglobin \< 10 g/dl
• Chronic kidney failure: glomerular filtration \< 60 ml/min/m\^2, nephrectomy, kidney transplantation
• Treatment with corticosteroids or immunosuppressive agents 3 months before surgery
• Transfusion of blood products during the previous 10 days
• Heart failure (New York Heart Association Functional Class 3 or 4) during the week before surgery.
• Heart valve diseases over stage B of the American College of Cardiology/American
• Heart Association Task Force on Practice Guidelines 2014

Sponsors & Collaborators

• Hospital General Universitario de Valencia: lead

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, 46014, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma samples

MeSH Terms

Conditions

Lung Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lung Injury; Pneumonia; Hypoxia; Postoperative Complications

Interventions

Thoracotomy; Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Thoracic Injuries; Wounds and Injuries; Respiratory Tract Infections; Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative; Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures

Study Officials

• Ana Broseta Lleó, Consultant

  Hospital General Universitario de Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Broseta Lleó, Consultant anaesthesiologist

CONTACT

656575897; ana.broseta@gmail.com

Ana Broseta Lleó, Consultant

CONTACT

656575897; ana.broseta@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 16, 2021
• Study Start: January 28, 2021
• Primary Completion: August 30, 2021
• Study Completion: October 31, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)