Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04677309 |
| Other study ID # |
THORUS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 20, 2020 |
| Est. completion date |
April 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Hospital General Universitario de Valencia |
| Contact |
Ana Broseta Lleó, Consultant |
| Phone |
0034963187554 |
| Email |
ana.broseta[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of the study is to assess whether lung ultrasound is able to detect lung injury
after lung resection surgery.
Description:
Postoperative pulmonary complications (PPC) are common after lung resection surgery, with an
incidence that ranges between 11-32%. As PPC are associated with worse outcomes, many studies
aim to find predictors that identify high risk patients and prompt specific interventions
and/or monitoring and hence, improve outcomes. PPC result from lung injury inherent to lung
resection surgery. Lung aeration changes seen with lung ultrasound (LUS) could detect lung
injury and thus, identify patients at high risk of PPC. The underlying mechanisms of lung
injury are different in the dependent and non-dependent lung; oxidative stress in both lungs,
lung injury associated with one-lung ventilation in the dependent lung and
ischemia/reperfusion or surgical manipulation in the non-dependent lung. LUS evaluates the
operated and non-operated lung separately and so it can be valuable in understanding the
characteristics and intensity of lung injury in each lung specifically.
This is a prospective, single-centre, observational study in which 28 consecutive
participants with non-small cell lung cancer scheduled for lobectomy will be recruited.
Participants will be divided in two groups depending on the surgical approach. First group
will be lobectomy via thoracotomy. Second group will be lobectomy via VATS. Participants will
be recruited consecutively until there are 14 patients in each group. LUS will be performed
in each participant's dependent and non-dependent lung at three predefined time points:
before surgery, after extubation and 24 h after surgery. Each hemithorax will be divided into
6 areas: anterior, lateral and posterior, separated by the anterior and posterior axillary
lines, each divided into upper and lower zones. For each echographic examination, cineloops
of the most pathological findings in each area will be stored and analysed offline by two
independent and blinded anesthesiologists. From these, a semiquantitative score, the modified
lung ultrasound score (mLUSS), will be calculated for each hemithorax to assess lung aeration
at each time point. The level of agreement for mLUSS will be tested. At the same predefined
time points blood plasma samples will be collected, flash-frozen and stored in order to
measure levels of the inflammatory mediators IL-6, IL-10 and TNFα.
The invertigators hypothesise that LUS can detect lung injury after lung resection surgery.
The primary objective of the study is to assess changes in lung aeration after lung resection
with mLUSS. Secondary objectives are, first, to describe LUS findings after lung resection
surgery, second, to assess the ability of mLUSS to detect oxygenation changes after lung
resection and third, to compare the behaviour of inflammatory mediators in plasma with mLUSS
changes.
