Postextubation Management in Patients at Risk for Extubation Failure

NCT04258020 | Terminated Results DMC FDA Device

• 1 other identifier: 1332767
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.

Conditions

Ventilatory Failure

Outcome Measures

Primary Outcomes (1)

• Re-intubation Within 72 Hours

  The number of patients who require re-intubation

  72 hours following extubation

Secondary Outcomes (6)

• Re-intubation Within 1 Week

  1 week following extubation

• Length of Stay

  Through hospital discharge, an average of 10.9 ± 1.91 days

• Ventilator Time

  Through hospital discharge, an average of 10.9 ± 1.91 days

• Mortality

  Through hospital discharge, an average of 10.9 ± 1.91 days

• Adverse Event Rate

  Through 1 week following extubation

Study Arms (2)

Experimental: alternating BiPAP and HFNC

EXPERIMENTAL

Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation

Device: BiPAP; Device: HFNC

Historical Control: standard of care

NO INTERVENTION

A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.

Interventions

BiPAP DEVICE

Bilevel Positive Airway Pressure (BiPAP) oxygen administration

Experimental: alternating BiPAP and HFNC

HFNC DEVICE

Heated High Flow Nasal Cannula oxygen administration

Experimental: alternating BiPAP and HFNC

Eligibility Criteria

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

You may qualify if:

• Documented high-risk factors of interest \[congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance\]
• The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L)
• Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation
• Only primary extubations will be included

You may not qualify if:

• Undergoing terminal extubation or placed on comfort care
• Home ventilator use
• Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC)

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

OhioHealth Grant Medical Center

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kiran Devulapally
• Organization: OhioHealth

kiran.devulapally@ohiohealth.com

614-566-9143

Study Officials

• Kiran Devulapally, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 6, 2020
• Study Start: February 11, 2020
• Primary Completion: February 25, 2020
• Study Completion: April 2, 2020
• Last Updated: January 13, 2022
• Results First Posted: January 13, 2022

Record last verified: 2022-01

Locations

US (1)