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NCT Number: NCT05060302

Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery

In postoperative thoracic surgery (lobe resection, pneumonectomy or wedge resection), cardiovascular complications are the most frequent (10 to 15%) with a significant morbi-mortality rate. Right ventricular (RV) dysfunction is a complication that can be multifactorial in post thoracic surgery. The RV longitudinal shortening fraction (RV-LSF) is a new 2D-STE parameters able to more accurately detect patients with RV dysfunction compared to conventional echocardiographic parameters.

This project is a single-center, prospective, interventional study of patients hospitalized at the Amiens University Hospital for scheduled thoracic surgery. TTE is performed preoperatively, at day 2 and day 15 following the thoracic surgery. Echocardiographic parameters will be measured by an echocardiographic expert in offline with a dedicated software. MACE criteria will be collected at day 2, day 15 and day-30 following the thoracic surgery.

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Key information

Conditions

Right Ventricle Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (>18 years)
  • Patient hospitalized at the Amiens University Hospital for scheduled thoracic surgery (lobectomy, pneumonectomy, wedge resection).
  • Surgery by thoracotomy or video-assisted thoracic surgery
  • Information of the patient and collection of his non-opposition

Exclusion criteria

  • Patient with poor echogenicity on TTE not allowing evaluation of 2D-STE or conventional parameters of the RV.
  • Patient with a rapid supraventricular rhythm disorder (HR > 100) at the time of TTE
  • Patient under mechanical ventilation
  • Patient under extracorporeal membrane oxygenation
  • Patients under guardianship or legal protection
  • Patients whose clinical condition does not allow for their non-opposition
  • Pregnant women

Treatment and study plan

transthoracic echocardiography (TTE)

Other

the included patients have a TTE preoperatively in order to evaluate the RV systolic function. TTE will also be done at day 2 and day-15 during the follow-up surgical consultation.

Primary outcomes

  1. occurrence of a major cardiovascular event (MACE)

    Time frame: day 30

    MACE is a composite criteria. MACES criteria is defined as the occurrence of at least one of the following events: A cardiovascular death or a documented supraventricular tachycardia (atrial fibrillation and/or flutter) of duration > 30 seconds or, an acute myocardial infarction or, an hospitalization for a right ventricular failure or, an hospitalization for a left ventricular failure.

Secondary outcomes

  1. Variation of RV systolic function from baseline in patients with MACE

    Time frame: at day 1

  2. Variation of RV systolic function from baseline in patients without MACE

    Time frame: at day 1

  3. Variation of RV systolic function from baseline in patients with MACE

    Time frame: at day 2

  4. Variation of RV systolic function from baseline in patients without MACE

    Time frame: at day 2

  5. Variation of RV systolic function from baseline in patients with MACE

    Time frame: at day 15

  6. Variation of RV systolic function from baseline in patients without MACE

    Time frame: at day 15

  7. Variation of RV systolic function from baseline in patients with MACE

    Time frame: within day 30

  8. Variation of RV systolic function from baseline in patients without MACE

    Time frame: within day 30

  9. Assessment of RV systolic function preoperatively

    Time frame: at day 30

  10. occurrence of a postoperative complication

    Time frame: at day 30

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study

Acronym: SPECKLETHO

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Sep 29, 2021
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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