NCT04677309

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

November 24, 2020

Last Update Submit

October 30, 2022

Conditions

Lung NeoplasmAdult ALLLung InjuryLung Injury, Ventilator InducedLung InflammationLung Ischemia/HypoxiaPostoperative ComplicationsPostoperative Respiratory ComplicationLung CancerThoracic

Keywords

thoracic surgerylung ultrasoundcytokines bloodlung injurypostoperative 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 findings 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

  • +1 more secondary outcomes

Study Arms (2)

Lung resection less than lobectomy

participants scheduled for lung resection that is less than lobectomy

Lung resection equal to or greater than lobectomy

participants scheduled for lung resection that is equal to or greater than lobectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 resection
  • Via VATS
  • Under one-lung ventilation

You may not qualify if:

  • pregnancy
  • Diagnosed pulmonary fibrosis
  • Scheduled surgery limited to biopsy
  • Surgery that includes resection of the thoracic wall or the diaphragm
  • Predicted FEV1 \< 40%
  • 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
  • Diastolic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 NeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaLung InjuryVentilator-Induced Lung InjuryPneumoniaHypoxiaPostoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesThoracic InjuriesWounds and InjuriesRespiratory Tract InfectionsInfectionsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ana Broseta Lleó, Consultant

    Hospital General Universitario de Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Broseta Lleó, Consultant

CONTACT

0034963187554ana.broseta@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant in Anesthesiology

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 21, 2020

Study Start

December 20, 2020

Primary Completion

December 30, 2022

Study Completion

April 1, 2023

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)