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

NCT03728452 | Completed

• 1 other identifier: 18/209-E
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Noninvasive Ventilation; Trophic Nutrition

Keywords

Trophic nutrition; high flow ventilation; noninvasive ventilation; mortality; complications

Outcome Measures

Primary Outcomes (1)

• Mortality

  Numbers of patients death at 90 days

  through study completion, an average of 2 year

Secondary Outcomes (2)

• Adverse effects

  through study completion, an average of 2 year

• Infections

  through study completion, an average of 2 year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Related Publications (21)

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Related Links

• Study ENVIN-HELICS. UCI infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: January 1, 2019
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)