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Trial record 6 of 10 for:    25003980 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728452
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborators:
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 Universitario Miguel Servet
Hospital Universitario Severo Ochoa
Hospital Universitario La Fe
Information provided by (Responsible Party):
Antonio Luis Blesa Malpica, Hospital San Carlos, Madrid

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
Noninvasive Ventilation Trophic Nutrition 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.


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Study Type : Observational
Estimated 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 : October 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy


Intervention Details:
  • Procedure: 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.



Primary Outcome Measures :
  1. Mortality [ Time Frame: through study completion, an average of 2 year ]
    Numbers of patients death at 90 days


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728452


Contacts
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Contact: Antonio Blesa Malpica 913303000 ext 7644 antonioluis.blesa@salud.madrid.org

Locations
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Spain
Fundacion para Investigación Biomedica Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Ana Belen Rivas Paterna, PhD    +34913303000 ext 7360    fibucicec.hcsc@salud.madrid.org   
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 Universitario Miguel Servet
Hospital Universitario Severo Ochoa
Hospital Universitario La Fe

Additional Information:
Publications:

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Responsible Party: Antonio Luis Blesa Malpica, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03728452     History of Changes
Other Study ID Numbers: 18/209-E
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Hospital San Carlos, Madrid:
Trophic nutrition
high flow ventilation
noninvasive ventilation
mortality
complications