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- Sperimentazione clinica NCT00534690
Does PEP Compensate the Reduction of Tidal Volume During One Lung Ventilation? (REVOLU)
Lowering VT and Increasing PEP During One-Lung Ventilation (OLV), Impact on Oxygenation
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Approval Status: Approved Approval Number: 2007-06 Board Name: CPP Sud Ouest et Outre-Mer 3 Board Affiliation: French Ministry of Health (DGS) Phone: Email: cpp.soom3@orange.fr No France: Afssaps - French Health Products Safety Agency
During general anesthesia, airway closure and the formation of atelectasis impair oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar recruitment when TV is reduced.
A recent study reported that mechanical ventilation with large intraoperative TV is associated with an increased risk of post-pneumonectomy respiratory failure. Indeed, large TV during OLV may lead to Ventilator-Induced Lung Injury (VILI) with the creation of alveolar stretch injury and the development of permeability pulmonary edema. The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. Therefore, once TV is reduced, PEP may play a key role in minimizing lung collapse and preventing lung units from repeated opening and collapse phases. Such "protective" ventilatory strategy may be proposed if it does not lead to hypoxemia during exclusion. We, therefore, study the impact on oxygenation, of increasing PEP in order to maintain recruitment, keeping Pplat constant when TV is reduced. We will compare, in each patient without severe pulmonary obstructive disease (FEV1 and FEV1 /CV > 70%), two strategies of ventilation with two different levels of TV and PEP, but keeping the same Pplat :
After induction of anesthesia, fiberoptic bronchoscopy confirms the correct position of the tube. Anesthesia is maintained with sevoflurane with a BIS® objective between 45 and 55. Boluses of sufentanyl and cisatracurium are done when clinically necessary. Patients are ventilated in VCV with a ZEUS® respiratory device (Dragger, Germany). Before incision, patients are switched to one-lung ventilation in the lateral position. The tidal volume (TV) is 8 ml/kg of ideal body weight, with a maximal plateau pressure limited to 32 cm H2O. The ventilatory frequency is adjusted in order to maintain end tidal concentrations of carbon dioxide (PetCO2) between 30 to 35 mmHg. 5 cmH2O of positive end expiratory pressure (PEP) is used, and the inspired oxygen fraction is adjusted in order to maintain the pulse oxymetry above 95%. During OLV, if SpO2 decreases to less than 90% with 100% of inspired oxygen fraction, surgery is temporarily stopped to resume two lungs ventilation until SpO2 recover at least 95%. If necessary, a continuous positive airway pressure (CPAP) with 5 cm H2O of oxygen is maintained to provide the non dependent lung. Datas are recorded when the chest is opened. The alveolar pressures and the inspiratory and expiratory flow time curves are monitored. After a period of 15 min, the two strategies are compared in a random order :
- TV of 8 ml/kg of ideal body weight and a PEP of 5 cmH2O during 10 minutes
- TV of 5 ml/kg and a PEP level in order to keep the same plateau pressure during 10 minutes.
Arterial blood gases are measured after 10 minutes using each strategy and before any vessels are ligated. The occurrence of PEPi is detected on the expiratory flow time curve.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pessac, Francia, 33604
- Département d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age> 18 years
- Open-chest thoracotomy for pulmonary resection
- oral consent
Exclusion Criteria:
- Severe obstructive disease (FEV1 or FEV1 /CV < 70%)
- Patient who don't tolerate a one-lung ventilation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Altro: 1
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Low Vt, High PEP
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Altro: 2
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High Vt, low PEP
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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PaO2/FiO2 after 10 minutes of each strategy
Lasso di tempo: 15 minutes after selective intubation and 10 minutes after the beginning of each ventilation type.
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15 minutes after selective intubation and 10 minutes after the beginning of each ventilation type.
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Occurrence of intrinsic PEP.
Lasso di tempo: Peroperative period
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Peroperative period
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Haemodynamic side effects: decrease of more than 20% of the arterial systolic blood pressure
Lasso di tempo: peroperative period
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peroperative period
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Hadrien ROZE, Dr, University Hospital, Bordeaux
- Cattedra di studio: Paul PEREZ, Dr, University Hospital (USMR), Bordeaux
Pubblicazioni e link utili
Pubblicazioni generali
- Fernandez-Perez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. doi: 10.1097/00000542-200607000-00007.
- Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. doi: 10.1097/01.anes.0000267607.25011.e8.
- Gothard J. Lung injury after thoracic surgery and one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):5-10. doi: 10.1097/01.aco.0000192783.40021.c1.
- Slinger P. Pro: low tidal volume is indicated during one-lung ventilation. Anesth Analg. 2006 Aug;103(2):268-70. doi: 10.1213/01.ane.0000223701.24874.c8. No abstract available.
- Senturk M. New concepts of the management of one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):1-4. doi: 10.1097/01.aco.0000192778.17151.2c.
- Michelet P, D'Journo XB, Roch A, Doddoli C, Marin V, Papazian L, Decamps I, Bregeon F, Thomas P, Auffray JP. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006 Nov;105(5):911-9. doi: 10.1097/00000542-200611000-00011.
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Primo inviato
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Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUBX 2007/06
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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