Clinical trial NCT03728452: Trophic Nutrition in Patients Submitted to High Flow Oxygen Therapy and / or Non Invasive Mechanical Ventilation
Official title: Trophic Nutrition in Patients Submitted to High Flow Oxygen Therapy and / or Non Invasive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noninvasive Ventilation
Trophic Nutrition
Keywords: Trophic nutrition
high flow ventilation
noninvasive ventilation
mortality
complications
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Gran Canaria Doctor Negrín
name: Hospital Universitario Fundación Jiménez Díaz
name: Hospital Barbastro
name: Hospital del Rio Hortega
name: Hospital Universitario Infanta Cristina
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitari Dr Josep Trueta
name: Hospital Universitario Infanta Leonor
name: Hospital Regional Universitario Carlos Haya
name: Hospital de Cruces
name: Hospital Universitario 12 de Octubre
name: Hospital Universitario Virgen de la Arrixaca
name: Hospital Virgen de la Concha
name: Hospital Universitario de Torrevieja
name: Complejo Hospitalario Universitario de Santiago
name: Hospital Universitario Puerto Real
name: Hospital Miguel Servet
name: Hospital Universitario Severo Ochoa
name: Hospital Universitario La Fe
First posted: 2018-11-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in 3 spanish Intensive Medicine Units (ICU) in need of oxygen therapy with high-flow cannula and / or non-invasive mechanical ventilation.

Brief summary: The decision about the initiation of enteral nutrition therapy in critically ill patients with oxygen therapy needs with HFC and / or NIMV is a matter of debate at present. Despite the benefits associated with this practice in critically ill patients, the scarcity of clinical studies in patients with sufficient methodological quality, as well as the absence of specific recommendations on enteral nutrition therapy in this type of patient, generates controversy in the professionals involved in critical patient care.

Detailed description: Ventilation and oxygenation of patients, even more in Intensive Care Units (ICUs), are in continuous development. The characteristics of patients, pathologies and diagnostic methods are constantly evolving. Among the main methods of ventilation and oxygenation that the investigators have are Non-invasive mechanical ventilation (NIMV) with face mask and high-flow cannula (HFC).

NIMV has represented an alternative in patients with failure to extubate, as an option before proposing a new reintubation. The ventilation with high flow has supposed an advance in the oxygenation of patients in situation of respiratory insufficiency, avoiding the intubation, and also has been a resource that allows the disconnection of the mechanical ventilator, reducing with it the time of mechanical support of the ventilation, There is a great amount of bibliography and a broad consensus on this aspect. Among the side effects widely studied, include bronchoaspiration, gastric insufflation, aerophagia and sialorrhea, which are usually well controlled with medical treatment.

The high flow ventilation consists of increasing the gas mixture, by releasing high oxygen and air flows, approximately up to 60 l/min, in modifiable proportions, so that positive pressures are achieved in the airway, facilitating the entry of this gas in the lung under spontaneous ventilation, with better oxygenation figures than conventional oxygen therapy methods. This positive pressure increase could be a facilitator of digestive intolerance either by air swallowing and gastric distension, or by promoting incontinence of the esophageal sphincters and thereby facilitating regurgitation and bronchoaspiration of the gastric contents.

NIMV consists of a ventilatory support applied without placement of endotracheal or pharyngeal devices, achieving increased alveolar ventilation by applying positive pressures throughout the airway through an interface (acting on the pressure gradient of the airway, to maintain an adequate gas exchange, impossible to achieve with spontaneous physiological ventilation). This positive pressure increase, as in ventilation with HFC, could also be an element that promotes digestive intolerance.

Patients in respiratory failure have a high level of metabolic stress that leads to a hypercatabolic situation and can not feed themselves for days, thus increasing the risk of malnutrition or worsening pre-existing malnutrition. This situation, as well as the development of negative energy balances in the critically ill patient, is associated with several complications, thus increasing morbidity and mortality, hospital stay and costs. The nutritional risk that this situation determines is high, which is why artificial nutrition therapy is justified. This nutritional therapy in spontaneous ventilation is usually attempted to be supplemented by oral feeding, but in patients who require artificial supports to aid in ventilation and oxygenation, it is not so easy to receive and tolerate adequate levels of caloric and protein intake. Enteral nutrition through the gastric route is frequently the method chosen for artificial nutritional therapy in patients with nutritional risk. This is due the advantages that the maintenance of the digestive tract in functional state will determine in the health of the patient, since the lack of nutrients in the lumen of the intestine can trigger a loss of the anatomical and functional integrity of the intestinal epithelium, with a rupture of the intestinal barrier that can favor, through a pro-inflammatory immune response, the evolution towards the multiple organ dysfunction syndrome.

Eligibility criteria: * INCLUSION CRITERIA:

  * Age ≥ 18 years.
  * Authorization to participate in the study through informed consent.
  * Patient with need of oxygen therapy with HFC and / or NIMV
  * NIMV or oxygen therapy time with HFC of at least 24 hours.
  * Expected survival over 72 hours.
  * Stay in ICU greater than or equal to 72 hours.
* EXCLUSION CRITERIA:

  * Age \<18 years.
  * Denial of authorization to participate in the study.
  * Patient who does not require oxygen therapy with HFC and / or NIMV
  * Absolute contraindication for the onset of TN (active digestive hemorrhage, intestinal obstruction, etc.) or patients with non-functioning gastrointestinal tract.

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Adverse effects
timeFrame: through study completion, an average of 2 year
measure: Infections
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Study officials:
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