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Adherence to LPV in SICU and Associated Clinical Outcomes

3 juin 2020 mis à jour par: Annop Piriyapatsom, MD, Mahidol University

Adherence Rate to Lung Protective Mechanical Ventilation in Patients Admitted to Surgical Intensive Care Units and Associated Clinical Outcomes

Lung Protective Ventilation strategy (LPV) with low tidal volume and adequate positive end-expiratory pressure is recommended for not only patients with acute respiratory distress syndrome (ARDS) but also those without ARDS too. From previous studies, adherence to LPV strategy reported is only 40% and data is limited in surgical patients. The investigators aim to describe ventilation management and find out the adherence rate to LPV strategy applied to surgical patients admitted to the surgical intensive care unit (SICU) and their associated outcomes.

Aperçu de l'étude

Description détaillée

Mechanical ventilation (MV) is one of the one organ support most frequently applied to patients admitted to intensive care units (ICUs). Despite considering as a life-saving intervention, MV may have detrimental effects, namely ventilator-induced lung injury (VILI). A mechanical breath with positive airway pressure may overstretch alveoli, especially in the non-dependent part of the lungs, and subsequently result in barotrauma and volutrauma. While cyclic opening and closing of alveoli during mechanical breath due to alveolar collapse at the end of expiration can cause atelec-trauma or cyclic atelectasis. All of these can lead to the activation of respiratory and systemic inflammatory response, so-called bio-trauma. To minimize the effects of MV on VILI, the lung protective mechanical ventilation (LPV) strategy have been proposed and now generally accepted as a standard practice in mechanically ventilated patients. The LPV strategy basically consists of ventilation with the low tidal volume of 6-8 mL/kg of predicted body weight (PBW) with limited plateau pressure of less than 30 cm H2O plus applying sufficient amount of positive end-expiratory pressure (PEEP) to prevent atelectasis. The LPV strategy has been clearly demonstrated benefits in not only patients with acute respiratory distress syndrome (ARDS) but also those with normal lungs including lessened respiratory and systemic inflammatory response and injured lungs, decreased duration of MV and length of stay (LOS), improved organ failure, and decreased pulmonary and other complications as well as mortality. Nevertheless, the adherence rate to the LPV strategy reported in the literatures is only approximately 40% in mechanically ventilated patients. For surgical patients, approximately 65% of those admitted to ICU require MV support either following operation or during their stay in ICU. To date, there is limited data regarding MV management in surgical patients who required MV support perioperatively. In addition, the difference in perioperative MV practices and their associated clinical outcomes has been not well determined in this setting. The aim of this study is to explore the current practice of MV according to the LPV strategy applied to surgical patients admitted to surgical ICU (SICU) and their associated clinical outcome. The primary outcome of this study is to determine the adherence rate to the LPV strategy at the initiation of MV support in mechanically ventilated patients in SICU. The LPV strategy in this study is defined as ventilation with the tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm of water. The secondary outcomes are factors associated with the adherence to the LPV strategy, incidences of pulmonary and other complications, LOS in SICU and in hospital, SICU and hospital discharge status, and status at 28 and 90 days following the initiation of MV support. Patients are divided into two groups, LPV and Non-LPV, according to their MV setting and clinical outcomes are statistically compared between groups.

Type d'étude

Observationnel

Inscription (Réel)

306

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Bangkok
      • Bangkoknoi, Bangkok, Thaïlande, 10700
        • Siriraj Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

All patients whose age of 18 years old or more admitted to two participating SICU and requiring MV support, either at SICU admission or during stay in SICU, via either endotracheal or tracheostomy tube with the anticipated duration of 12 hours or more without exclusion criteria are included.

La description

Inclusion Criteria:

  • Patients whose age of 18 years old or more
  • Patients admitted to two participating SICU
  • Patients requiring MV support with the anticipated duration of 12 hours or more

Exclusion Criteria:

  • Patients not requiring MV support during SICU stay
  • Patients requiring MV support for less than 12 hours in SICU
  • Patients requiring MV support for more than 24 hours prior to SICU admission
  • Patients included in this study once and re-admitted to the SICU
  • Patients requiring non-invasive MV support
  • Moribund or terminal cases
  • Patients who refuse to participate in the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
LPV
Patients receive LPV strategy at the initiation of MV support. The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O.
Non-LPV
Patients do not receive LPV strategy at the initiation of MV support.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Adherence rate to LPV strategy at the initiation of MV support
Délai: During the first 24 hours following the initiation of MV support
The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O.
During the first 24 hours following the initiation of MV support

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidences of pulmonary and other complications
Délai: During the first 7 consecutive days following the initiation of MV support
Pulmonary complications include pneumonia, ARDS, atelectasis, restoration of MV support after liberation from MV, pleural effusion, cardiogenic pulmonary edema, pneumothorax and new pulmonary infiltration. Other complications include stroke, myocardial ischemia/infarction, arrhythmias, acute kidney injury, sepsis, new infection other than pneumonia, and re-admission to the SICU.
During the first 7 consecutive days following the initiation of MV support
Length of stay in SICU and in hospital
Délai: Up to 90 days following the initiation of MV support
Total days of stay in SICU and in hospital following the initiation of MV support.
Up to 90 days following the initiation of MV support
SICU and hospital discharge status, and status at 28 and 90 days
Délai: Up to 90 days following the initiation of MV support
Status whether alive or decease
Up to 90 days following the initiation of MV support

Collaborateurs et enquêteurs

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Publications et liens utiles

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Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 avril 2018

Achèvement primaire (Réel)

30 juin 2019

Achèvement de l'étude (Réel)

20 mars 2020

Dates d'inscription aux études

Première soumission

27 septembre 2018

Première soumission répondant aux critères de contrôle qualité

5 octobre 2018

Première publication (Réel)

9 octobre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juin 2020

Dernière vérification

1 juin 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 077/2561(EC4)

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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