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High-Flow Oxygen Therapy Following Tracheostomy

NCT03721419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-07-20

No results posted yet for this study

Summary

Respiratory failure patients sometimes receive tracheostomy due to difficulty weaning from mechanical ventilation. Efforts to wean patients with a tracheostomy usually involve the administration of oxygen via High Humidity device. There are two major ways of administering oxygen to patients which include low flow delivered at less than 10Liters per minute (LPM) and high-flow delivered at greater than 10LPM. There is not a currently accepted standard of care practice for how to administer oxygen therapy to these patients. Both Low and High Flow are accepted practices in the US.

Conditions

  • Acute Respiratory Failure

Interventions

DEVICE

High Flow High Humidity device

High Flow High Humidity device has a flow generator built into the body of unit and can deliver flows between 10 to 60 Liters per minute (LPM) with oxygen bled in as needed in order to deliver specified Fraction of inspired Oxygen (FiO2)

DEVICE

Low Flow High Humidity device

Standard high humidity trach collar utilizing venturi device bleed in

Sponsors & Collaborators

  • Barnes-Jewish Hospital

    lead OTHER

Principal Investigators

  • Marin Kollef, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2020-03-30
Completion
2020-04-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03721419 on ClinicalTrials.gov