Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy

Esophageal Neoplasm Clinical Trial

— OESOLUS  

Official title:

Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy: A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453760
• Other study ID #: 2022_0076
• Secondary ID: 2022-A00655-38
• Status: Recruiting
• Start date: August 21, 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Lille
• Contact: Cédric CIRENEI, MD,PhD
• Phone: 0320445962
• Email: cedric.cirenei[@]chu-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Thoracic Esophagectomy

Exclusion Criteria:

• Emphysema Death during surgery Refusal

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of the Lung ultrasound score		at Day 0 (within 1 hour of tracheal extubation)
Secondary	The presence of condensations on pleuropulmonary ultrasound in the ICU		at Day 1 and Day 3
Secondary	The presence of pleural effusion at D0, D1 or D3		at Day 0, Day 1 and Day 3
Secondary	Diaphragmatic excursion is measured via subcostal diaphragmatic ultrasound performed during the patient's clinical examination		at Day 0, Day 1 and Day 3
Secondary	Complications according to the Dindo-Clavien classification		at Day 7