Postextubation Management in Patients at Risk for Extubation Failure

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04258020

Enrollment

Registered

2020-02-06

Start date

2020-02-11

Completion date

2020-04-02

Last updated

2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilatory Failure

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.

Interventions

DEVICEBiPAP

Bilevel Positive Airway Pressure (BiPAP) oxygen administration

DEVICEHFNC

Heated High Flow Nasal Cannula oxygen administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Re-intubation Within 72 Hours	72 hours following extubation	The number of patients who require re-intubation

Secondary

Measure	Time frame	Description
Length of Stay	Through hospital discharge, an average of 10.9 ± 1.91 days	Hospital length of stay
Ventilator Time	Through hospital discharge, an average of 10.9 ± 1.91 days	The total duration of time patients spend on a ventilator
Re-intubation Within 1 Week	1 week following extubation	The number of patients who require re-intubation
Adverse Event Rate	Through 1 week following extubation	The proportion of patients experiencing an adverse event
30-day Readmission	30 days following discharge	The proportion of patients who require re-admission within 30 days of discharge
Mortality	Through hospital discharge, an average of 10.9 ± 1.91 days	The proportion of patients who expire during the hospital stay

Countries

United States

Participant flow

Pre-assignment details

Two participants in the experimental group withdrew from the study prior to intervention. One participant in the experimental group withdrew consent at time of regained capacity. Because the study was terminated (halted prematurely) no data were collected for the historical control group.

Participants by arm

Arm	Count
Experimental: Alternating BiPAP and HFNC Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation BiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration HFNC: Heated High Flow Nasal Cannula oxygen administration	3
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.	0
Total	3

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Experimental: Alternating BiPAP and HFNC	Total
Age, Categorical <=18 years	0 Participants	0 Participants
Age, Categorical >=65 years	2 Participants	2 Participants
Age, Categorical Between 18 and 65 years	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants
Race (NIH/OMB) White	2 Participants	2 Participants
Region of Enrollment United States	3 participants	3 participants
Sex: Female, Male Female	2 Participants	2 Participants
Sex: Female, Male Male	1 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 3	0 / 0
other Total, other adverse events	1 / 3	0 / 0
serious Total, serious adverse events	0 / 3	0 / 0

Outcome results

Primary