Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery

• Conditions: Thoracic; Pulmonary Restrictive Disease; ARDS

• Registration Number: NCT04818554
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The improvement in ARDS mortality over the last 20 years seems to be largely explained by the reduction of mechanical ventilation-induced injury (VILI). VILI is essentially related to volotrauma closely associated with "strain" and "stress". The pulmonary stress corresponds to the transpulmonary pressure (alveolar pressure - pleural pressure), and the strain to the change in lung volume related to the functional residual capacity (FRC) of the injured lung at PEEP = 0. The volotrauma corresponds therefore to the generalized excess of stress and strain on the injured lung.

The initial therapeutic strategy consists in protective ventilation with a tidal volume of 6 ml/kg of theoretical ideal weight (predicted by height), associated with a high respiratory rate between 25 and 30 cycles per minute to control PaCO2 (\< 50 mmHg), apply a high positive expiratory pressure PEEP according to FiO2, maintain a plateau pressure (PP) lower than 30 cmH20, reduce instrumental dead space, use curarization, recruitment maneuvers such as alternate prone, improve ventilation-perfusion adequacy using inhaled NO.

As a last resort, extracorporeal oxygenation by veno-venous ECMO is a device to supplement respiratory function by improving oxygenation and ensuring decarboxylation. Veno-venous ECMO is indicated in severe ARDS with PaO2/FiO2 \< 80 mmHg and/or when mechanical ventilation becomes unsafe due to increased plateau pressure despite optimized ARDS management including high PEEP levels, curarization and prone position.

After lung resection surgery, the incidence of ARDS is 2-8% and its prognosis remains more poor, despite advances in management, with a mortality of up to 60%. Risk factors include intraoperative vascular filling, type of pulmonary resection, and predicted postoperative respiratory function. Early support with VV ECMO is vital in some patients to treat severe hypoxemia, due to variable surgical reduction of lung parenchyma depending on carcinological involvement or initial lung pathology. ). There are very few data concerning these patients with pulmonary resection. The primary objective of this study is to describe the prevalence of ARDS and the risk factors for its occurrence after pulmonary resection surgery. The secondary objective is to compare the ventilation parameters (especially motor pressure) in patients with reduced lung parenchyma in ARDS under VV ECMO with those who did not use VV ECMO assistance.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
risk factors for its occurrence after pulmonary resection surgery	1 day	risk factors for its occurrence after pulmonary resection surgery
Prevalence of ARDS	1 day	Prevalence of ARDS after pulmonary resection surgery

Secondary Outcome Measures

Name	Time	Method
According to the usual clinico-biological data of monitoring in intensive care	1 day	According to the usual clinico-biological data of monitoring in intensive care

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France