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

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Recruiting
CT.gov ID
NCT03728452
Collaborator
Hospital Universitario de Gran Canaria Doctor Negrín (Other), Hospital Universitario Fundación Jiménez Díaz (Other), Hospital Barbastro (Other), Hospital del Río Hortega (Other), Hospital Universitario Infanta Cristina (Other), Hospital Universitario Ramon y Cajal (Other), Hospital Universitari Dr Josep Trueta (Other), Hospital Universitario Infanta Leonor (Other), Hospital Regional Universitario Carlos Haya (Other), Hospital Universitario Cruces (Other), Hospital Universitario 12 de Octubre (Other), Hospital Universitario Virgen de la Arrixaca (Other), Hospital Virgen de la Concha (Other), Hospital Universitario de Torrevieja (Other), Complejo Hospitalario Universitario de Santiago (Other), Hospital Universitario Puerto Real (Other), Hospital Miguel Servet (Other), Hospital Universitario Severo Ochoa (Other), Hospital Universitario La Fe (Other)
310
1
36
8.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Trophic Nutrition

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
310 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Trophic Nutrition in Patients Submitted to High Flow Oxygen Therapy and / or Non Invasive
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Feb 9, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Mortality [through study completion, an average of 2 year]

    Numbers of patients death at 90 days

Secondary Outcome Measures

  1. Adverse effects [through study completion, an average of 2 year]

    Numbers of Regurgitation, Vomits, Distension of Bronchoaspiration

  2. Infections [through study completion, an average of 2 year]

    numbers of all infections

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fundacion para Investigación Biomedica Hospital Clinico San Carlos Madrid Spain 28040

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Antonio Luis Blesa Malpica, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT03728452
Other Study ID Numbers:
  • 18/209-E
First Posted:
Nov 2, 2018
Last Update Posted:
Sep 30, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antonio Luis Blesa Malpica, Principal Investigator, Hospital San Carlos, Madrid

Study Results

No Results Posted as of Sep 30, 2021