Nutritional Therapy in Patients With Post-extubation Dysp... | NCT06511284

Studies
Nutritional Therapy in Patients With Post-extubation Dysphagia

NCT06511284

Sponsor

National Institute of Respiratory Diseases, Mexico

Status

Recruiting

Last Update Posted

Jul 19, 2024Actual

Enrollment

128Estimated

Phase

Not Applicable

Conditions

Dysphagia

Interventions

High protein dose
Usual protein dose

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Jul 10, 2024

First Submission Date that Met QC Criteria

Jul 15, 2024

First Posted Date

Jul 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2024

Last Update Posted Date

Jul 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ivan Armando Osuna Padilla, Clinical Nutrition Manager, National Institute of Respiratory Diseases, MexicoPrincipal Investigator

Lead Sponsor

National Institute of Respiratory Diseases, MexicoOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the impact of the prescription of two doses of protein on the amount in kilograms of muscle mass and on the clinical evolution (time until safe swallowing, time until removal of the feeding stoma, number of hospital readmissions, feeding stoma infections, incidence of pneumonia, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High protein group	Experimental	100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g/kg, will be prescribed	Other: High protein dose
Usual protein group	Other	100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g/kg, will be prescribed.	Other: Usual protein dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High protein dose	Other	High dose of protein (2.0 g/kg) will prescribed for home enteral nutrition	High protein group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle mass changes	Changes of muscle mass in kilograms measured by impedance bioelectric	From randomization to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Swallow recovery	Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months	From randomization to 6 months
Duration of enteral nutrition indication

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who required invasive mechanical ventilation during their hospital stay with a diagnosis of post-extubation dysphagia diagnosed by fibroendoscopy evaluation of swallowing (FEES).
Patients who discharged with a feeding tube.
Patients with signed informed consent.

Exclusion Criteria:

Patients with pre-existing dysphagia, or with neurological conditions that can cause dysphagia (e.g. multiple sclerosis, Parkinson's disease, Alzheimer's, myasthenia gravis).
Patients with chronic kidney disease, defined as a glomerular filtration rate <60 ml/min.
Patients discharged with a terminal condition and/or life expectancy of less than 3 months.
Diagnosis of HIV, upon receiving clinical follow-up by the team of specialists.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ivan A Osuna-Padilla, PhD	Contact	+5216671035806		ivan.osuna@iner.gob.mx
Alan Garcia-Grimaldo, MSc	Contact			agarciag1716@gmail.com

Overall Officials

Name	Affiliation	Role
Ivan A Osuna-Padilla, PhD	Instituto Nacional de Enfermedades Respiratorias	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Respiratory Diseases	Recruiting	Mexico City		14080	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided