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Tracheostomy With Bedside Simultaneous Gastrostomy Vs Usual Care Tracheostomy And Delayed Gastrostomy Placement

NCT04758052 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-06-09

No results posted yet for this study

Summary

There is currently no prospective study analyzing the effect of tracheostomy with bedside simultaneous gastrostomy versus tracheostomy with delayed gastrostomy placement (TSG versus TDG) on the outcomes of neurocritically-ill patients. The investigators will study TSG via concomitant PDT and PUG procedures, while TDG will occur per usual care. This study is a prospective randomized open-label blinded endpoint study to assess the effect of tracheostomy with bedside simultaneous gastrostomy (TSG) versus the usual care of tracheostomy with delayed gastrostomy (TDG) placement on outcomes of neurocritically-ill patients.

Conditions

  • Stroke, Acute
  • TBI
  • Neuromuscular Diseases
  • Status Epilepticus
  • Coma
  • Cerebrovascular Disorders
  • Spinal Cord Injuries
  • Neurological Injury
  • Neurologic Injury

Interventions

OTHER

Timing of placement

Simultaneous placement of tracheostomy and gastrostomy

Sponsors & Collaborators

  • University of Mississippi Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-01-31
Completion
2022-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758052 on ClinicalTrials.gov