- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04818554
Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery (ARDS_THO)
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Montpellier, Frankrike, 34295
- Rekrytering
- UH Montpellier
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Kontakt:
- hélène David, PhD
- Telefonnummer: 33 629834346
- E-post: h-david@chu-montpellier.fr
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion criteria:
- Patient hospitalized following ARDS after thoracic resection surgery
Exclusion criteria:
- Refusal to participate after receiving the information letter
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Prevalence of ARDS
Tidsram: 1 day
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Prevalence of ARDS after pulmonary resection surgery
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1 day
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risk factors for its occurrence after pulmonary resection surgery
Tidsram: 1 day
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risk factors for its occurrence after pulmonary resection surgery
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1 day
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
According to the usual clinico-biological data of monitoring in intensive care
Tidsram: 1 day
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According to the usual clinico-biological data of monitoring in intensive care
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1 day
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: hélène David, PHD, UH Montpellier
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- RECHMPL21_0191
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