Postextubation Management in Patients at Risk for Extubation Failure

Ventilatory Failure Clinical Trial

Official title:

Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04258020
• Other study ID #: 1332767
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Hypoventilation
• Ventilatory Failure

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