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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04258020
Other study ID # 1332767
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 11, 2020
Est. completion date April 2, 2020

Study information

Verified date January 2022
Source OhioHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging. Evidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients. The purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date April 2, 2020
Est. primary completion date February 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BiPAP
Bilevel Positive Airway Pressure (BiPAP) oxygen administration
HFNC
Heated High Flow Nasal Cannula oxygen administration

Locations

Country Name City State
United States OhioHealth Grant Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Re-intubation Within 72 Hours The number of patients who require re-intubation 72 hours following extubation
Secondary Re-intubation Within 1 Week The number of patients who require re-intubation 1 week following extubation
Secondary Length of Stay Hospital length of stay Through hospital discharge, an average of 10.9 ± 1.91 days
Secondary Ventilator Time The total duration of time patients spend on a ventilator Through hospital discharge, an average of 10.9 ± 1.91 days
Secondary Mortality The proportion of patients who expire during the hospital stay Through hospital discharge, an average of 10.9 ± 1.91 days
Secondary Adverse Event Rate The proportion of patients experiencing an adverse event Through 1 week following extubation
Secondary 30-day Readmission The proportion of patients who require re-admission within 30 days of discharge 30 days following discharge
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