NCT04258020

Postextubation Management in Patients at Risk for Extubation Failure

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: OhioHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ventilatory Failure

Interventions

Type	Name	Description
DEVICE	BiPAP	Bilevel Positive Airway Pressure (BiPAP) oxygen administration
DEVICE	HFNC	Heated High Flow Nasal Cannula oxygen administration

Timeline

• Start date: 2020-02-11
• Primary completion: 2020-02-25
• Completion: 2020-04-02
• First posted: 2020-02-06
• Last updated: 2022-01-13
• Results posted: 2022-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study