Postextubation Management in Patients at Risk for Extubation Failure

NCT ID: NCT04258020

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2020-04-02

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental: alternating BiPAP and HFNC

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

Group Type: EXPERIMENTAL

BiPAP

Intervention Type: DEVICE

Bilevel Positive Airway Pressure (BiPAP) oxygen administration

HFNC

Intervention Type: DEVICE

Heated High Flow Nasal Cannula oxygen administration

Historical Control: standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BiPAP

Bilevel Positive Airway Pressure (BiPAP) oxygen administration

Intervention Type: DEVICE

HFNC

Heated High Flow Nasal Cannula oxygen administration

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiran Devulapally, MD

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

OhioHealth Grant Medical Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1332767

Identifier Type: -

Identifier Source: org_study_id