Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery

ARDS Clinical Trial

— ARDS_THO  

Official title:

Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04818554
• Other study ID #: RECHMPL21_0191
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Montpellier
• Contact: Hélène David, PHD
• Phone: 629834346
• Email: h-david[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patient hospitalized following ARDS after thoracic resection surgery

Exclusion criteria:

• Refusal to participate after receiving the information letter

Related Conditions & MeSH terms

• ARDS
• Pulmonary Restrictive Disease
• Thoracic

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of ARDS	Prevalence of ARDS after pulmonary resection surgery	1 day
Primary	risk factors for its occurrence after pulmonary resection surgery	risk factors for its occurrence after pulmonary resection surgery	1 day
Secondary	According to the usual clinico-biological data of monitoring in intensive care	According to the usual clinico-biological data of monitoring in intensive care	1 day