Postextubation Management in Patients at Risk for Extubation Failure

OhioHealth6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Ventilatory Failure

Interventions

BiPAPDEVICE

Bilevel Positive Airway Pressure (BiPAP) oxygen administration

HFNCDEVICE

Heated High Flow Nasal Cannula oxygen administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

OhioHealth Grant Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Re-intubation Within 72 Hours

The number of patients who require re-intubation

Time frame: 72 hours following extubation

Secondary Outcomes

Re-intubation Within 1 Week

The number of patients who require re-intubation

Time frame: 1 week following extubation

Length of Stay

Hospital length of stay

Time frame: Through hospital discharge, an average of 10.9 ± 1.91 days

Ventilator Time

The total duration of time patients spend on a ventilator

Time frame: Through hospital discharge, an average of 10.9 ± 1.91 days

Mortality

The proportion of patients who expire during the hospital stay

Time frame: Through hospital discharge, an average of 10.9 ± 1.91 days

Adverse Event Rate

The proportion of patients experiencing an adverse event

Time frame: Through 1 week following extubation

30-day Readmission

The proportion of patients who require re-admission within 30 days of discharge

Time frame: 30 days following discharge

Data from ClinicalTrials.gov

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