Clinical trial NCT05453760: Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy
Official title: Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Neoplasm
Keywords: Thoracic Esophagectomy
Esophagectomy
Postoperative pulmonary complications
lung ultrasound
critical care
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective cohort study of esophagectomy patients in a tertiary hospital

Brief summary: The perioperative management of esophageal cancer has evolved considerably in recent years.

Over the last 30 years, postoperative mortality has been steadily decreasing. However, respiratory morbidity remains high (30-40%). This is due to the procedure itself requiring a thoracic approach and intraoperative unipulmonary ventilation. The postoperative pulmonary complications (PPCs) are multiple: bronchial congestion, atelectasis, pneumopathy, acute respiratory distress syndrome (ARDS), liquid pleural effusion, pneumothorax.

In general, prevention and early treatment are aimed at limiting the evolution towards acute respiratory failure requiring ventilatory assistance.

Chest radiography is essential for the presumptive diagnosis of pneumopathy in particular, but the interpretation of the images may be difficult.

Thoracic computed tomography (CT) is the gold standard because it is sensitive and can discriminate among differential diagnoses. This is difficult to perform: it requires intra-hospital transport of patient, who is often in acute respiratory failure, and the availability of an examination area.

Lung ultrasound is used at the bedside for diagnosis of lung infection in intensive care unit. This has a sensitivity close to thoracic CT and has the advantage of being feasible at any time, does not require transport of the patient and is not irradiating.

Lung ultrasound allows early detection of the need for ventilatory support in postoperative major abdominal surgery . In addition, the sensitivity of lung ultrasound is close to that of CT, allowing this examination to be relied upon.

The main objective of the study is to determine the role of lung ultrasound in the prediction of postoperative pulmonary complications within one hour after extubation.


Eligibility criteria: Inclusion Criteria:

* Thoracic Esophagectomy

Exclusion Criteria:

* Emphysema Death during surgery Refusal

Primary outcomes:
measure: Area under the curve (AUC) of the Lung ultrasound score
timeFrame: at Day 0 (within 1 hour of tracheal extubation)
Secondary outcomes:
measure: The presence of condensations on pleuropulmonary ultrasound in the ICU
timeFrame: at Day 1 and Day 3
measure: The presence of pleural effusion at D0, D1 or D3
timeFrame: at Day 0, Day 1 and Day 3
measure: Diaphragmatic excursion is measured via subcostal diaphragmatic ultrasound performed during the patient's clinical examination
timeFrame: at Day 0, Day 1 and Day 3
measure: Complications according to the Dindo-Clavien classification
timeFrame: at Day 7
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Cédric CIRENEI, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: