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

NCT ID: NCT03728452

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-02-01

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.

Conditions

Noninvasive Ventilation; Trophic Nutrition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Trophic Nutrition

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario de Gran Canaria Doctor Negrín

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario Fundación Jiménez Díaz

OTHER

Sponsor Role: collaborator

Hospital Barbastro

UNKNOWN

Sponsor Role: collaborator

Hospital del Rio Hortega

OTHER

Sponsor Role: collaborator

Hospital Universitario Infanta Cristina

OTHER

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

University Hospital of Girona Dr. Josep Trueta

NETWORK

Sponsor Role: collaborator

Hospital Universitario Infanta Leonor

OTHER

Sponsor Role: collaborator

Hospital Regional Universitario Carlos Haya

OTHER

Sponsor Role: collaborator

Hospital de Cruces

OTHER

Sponsor Role: collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role: collaborator

Hospital Virgen de la Concha

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario de Torrevieja

UNKNOWN

Sponsor Role: collaborator

Complejo Hospitalario Universitario de Santiago

OTHER

Sponsor Role: collaborator

Hospital Universitario Puerto Real

OTHER

Sponsor Role: collaborator

Hospital Miguel Servet

OTHER

Sponsor Role: collaborator

Hospital Universitario Severo Ochoa

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role: collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Antonio Luis Blesa Malpica

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, , Spain

Countries

Spain

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Related Links

http://hws.vhebron.net/envin-helics/Help/Manual_2018.pdf

Study ENVIN-HELICS. UCI infections

Other Identifiers

18/209-E

Identifier Type: -

Identifier Source: org_study_id