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

Recruiting

• Conditions: Esophageal Neoplasm

• Registration Number: NCT05453760
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-08-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• Thoracic Esophagectomy

Exclusion Criteria

• Emphysema Death during surgery Refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of the Lung ultrasound score	at Day 0 (within 1 hour of tracheal extubation)

Secondary Outcome Measures

Name	Time	Method
The presence of pleural effusion at D0, D1 or D3	at Day 0, Day 1 and Day 3
Diaphragmatic excursion is measured via subcostal diaphragmatic ultrasound performed during the patient's clinical examination	at Day 0, Day 1 and Day 3
Complications according to the Dindo-Clavien classification	at Day 7
The presence of condensations on pleuropulmonary ultrasound in the ICU	at Day 1 and Day 3

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France