Postextubation Management in Patients at Risk for Extubation Failure

OhioHealth

Status: Terminated

Conditions: Ventilatory Failure

Treatments: Device: HFNC; Device: BiPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT04258020

1332767

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Experimental: alternating BiPAP and HFNC

Experimental group

Description:

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

Treatment:

Device: BiPAP

Device: HFNC

Historical Control: standard of care

No Intervention group

Description:

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