NCT04677309

Brief Summary

The purpose of this prospective observational study is to assess perioperative changes in lung aeration after lung resection surgery using lung ultrasound, and to explore their relationship with oxygenation, inflammatory biomarkers, cardiac stress markers and diaphragmatic function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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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
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

November 24, 2020

Last Update Submit

June 16, 2026

Conditions

Keywords

thoracic surgerylung ultrasoundlung aerationlung ultrasound scorelung resectionlobectomyone-lung ventilationpostoperative pulmonary complicationsoxygenationcytokinesNT-proBNPdiaphragmatic function

Outcome Measures

Primary Outcomes (1)

  • Change in lung aeration after lung resection surgery assessed by lung ultrasound score

    The lung ultrasound score is a semiquantitative score used to assess lung aeration. Higher values indicate greater loss of aeration. Changes will be assessed between the preoperative period, the immediate postoperative period after extubation, and 24 hours after surgery.

    preoperative vs immediate postoperative period vs 24 hours after surgery

Secondary Outcomes (5)

  • Regional distribution of lung ultrasound findings in the operated and non-operated lung

    preoperative vs immediate postoperative period vs 24 hours after surgery

  • Changes in oxygenation after lung resection surgery

    preoperative vs immediate postoperative vs 24 hours after surgery

  • Changes in plasma inflammatory biomarkers after lung resection surgery

    preoperative vs immediate postoperative vs 24 hours after surgery

  • Changes in cardiac stress markers after lung resection surgery

    preoperative vs immediate postoperative vs 24 hours after surgery

  • Changes in diaphragmatic function after lung resection surgery

    preoperative vs immediate postoperative vs 24 hours after surgery

Study Arms (1)

Lung resection surgery

Adult patients scheduled for elective lobectomy surgery under one-lung ventilation in a tertiary referral hospital.

Diagnostic Test: Perioperative lung ultrasound assessment

Interventions

Lung ultrasound was performed at three predefined perioperative time points: before surgery, in the immediate postoperative period after extubation, and 24 hours after surgery. Each hemithorax was assessed in six regions, and lung aeration was evaluated using a semiquantitative lung ultrasound score.

Lung resection surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective lung resection surgery at a tertiary referral hospital.

You may qualify if:

  • Age \> 18
  • ASA I-III
  • Non-small cell lung neoplasm
  • Elective lobectomy
  • 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 score \> 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
  • Previously documented elevated left atrial pressure or cardiac disease associated with elevated left-sided filling pressures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma samples

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ana Broseta Lleó, Consultant

    Hospital General Universitario de Valencia

    PRINCIPAL INVESTIGATOR

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

January 30, 2022

Study Completion

April 30, 2022

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations