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NCT Number: NCT03728452

Trophic Nutrition in Patients Submitted to High Flow Oxygen Therapy and / or Non Invasive Mechanical Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Trophic Nutrition

Procedure

According to previously published studies of Trophic Nutritions in critically ill patients, an energy goal of 20-30% estimated caloric needs of 20-30 kcal / kg and a protein intake of 1.2 to 2.0 g / kg / day of proteins will be established. at most 72 hours after the start of nutritional therapy.

The rhythm of initiation and increase of enteral contributions will be at the discretion of each participating ICU. Prokinetic or parenteral nutrition (PN) complementary will not be used routinely, leaving its indication at the discretion of the responsible physician.

A hyperproteic nutritional formula (10 g / 100 ml) will be used, with a caloric intake of 1.2 kcal / ml and a non-protein kcal / nitrogen ratio of 52: 1. TN will be administered over 23 hours each day by continuous infusion pump. The head of the patient's bed will rise above 30° as much as possible to reduce the risk of aspiration. The Gastric Residue Volume (GRV) will be measured every 24 hours.

Primary outcomes

  1. Mortality

    Time frame: through study completion, an average of 2 year

    Numbers of patients death at 90 days

Secondary outcomes

  1. Adverse effects

    Time frame: through study completion, an average of 2 year

    Numbers of Regurgitation, Vomits, Distension of Bronchoaspiration

  2. Infections

    Time frame: through study completion, an average of 2 year

    numbers of all infections

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • Complejo Hospitalario Universitario de Santiago
  • Hospital Barbastro
  • Hospital Miguel Servet
  • Hospital Regional Universitario Carlos Haya
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario Infanta Cristina
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario La Fe
  • Hospital Universitario Puerto Real
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Severo Ochoa
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitario de Gran Canaria Doctor Negrín
  • Hospital Universitario de Torrevieja
  • Hospital Virgen de la Concha
  • Hospital de Cruces
  • Hospital del Rio Hortega
  • University Hospital of Girona Dr. Josep Trueta

Registry information

Official study title

Trophic Nutrition in Patients Submitted to High Flow Oxygen Therapy and / or Non Invasive

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Nov 2, 2018
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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