Noninvasive Ventilation Weaning Protocol in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-04-01

Brief Summary

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Noninvasive ventilation (NIV) has revolutionized the management of patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with hypercapnic respiratory failure (HcRF). NIV use has been shown to reduce the need for endotracheal intubation, hospital and intensive care unit (ICU) length of stay, and mortality.

Multiple studies have been conducted on weaning strategies among patients requiring invasive mechanical ventilation. As a result of these studies, definite criteria and protocols have been laid down for weaning from invasive mechanical ventilation. However, no such data are available for the withdrawal of NIV.

Evidence-based reviews suggest that protocols to manage the weaning and liberation of subjects from Mechanical Ventilation could reduce the time that subjects spend receiving mechanical ventilation. However, no such data about protocolized withdrawal of NIV are available.

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Detailed Description

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A study to compare protocolized weaning from non-invasive ventilation using three potential strategies of weaning from NIV

* Stepwise reduction of duration of NIV use,
* Stepwise reduction in pressure support of NIV, and
* Immediate withdrawal of NIV. Among patients with Acute respiratory failure due to acute exacerbation of COPD.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participant is assigned to only one of the three intervention groups (gradual pressure support decrement, gradual time spent on noninvasive per day decrement, abrupt withdrawal of noninvasive ventilatory support) for the entire duration of the weaning period.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the nature of the interventions, participants and clinical staff managing the weaning will not be blinded to group assignment. However, outcome assessors \[the physician adjudicating weaning success based on predefined criteria\] and data analysts will be blinded to group allocation throughout the outcome assessment and analysis phases

Study Groups

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Gradual PS Decrement

): pressure support will be reduced by 2-4 cm H2O every 6-8 h with vitals and blood gas monitoring till IPAP of \<8 cm of H2O and EPAP of \<4 cm of H2O is attained, after which NIV will be completely withdrawn

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type DEVICE

Weaning from noninvasive ventilation for patients with acute exacerbation of COPD

Gradual Time Decrement

the duration of NIV will be reduced to 16 h on the day of randomization (day 0), then reduced to 12 h on day 1 (including 6-8 h of overnight use), 6-8 h of overnight use on day 2, and complete withdrawal on day 3.

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type DEVICE

Weaning from noninvasive ventilation for patients with acute exacerbation of COPD

Abrupt Withdrawal

patients will be immediately withdrawn from NIV and monitored on spontaneous breathing.

Group Type ACTIVE_COMPARATOR

Noninvasive ventilation

Intervention Type DEVICE

Weaning from noninvasive ventilation for patients with acute exacerbation of COPD

Interventions

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