Noninvasive Ventilation Weaning Protocol in COPD

Assiut University

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Noninvasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07133711

WGEK-NIV-Weaning-Trial

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All COPD patients admitted in the respiratory ICU with acute Hypercapnic Respiratory Failure who will be managed with Noninvasive Ventilation without the need for invasive mechanical ventilation will be eligible for inclusion in the study.

Exclusion criteria

• Age: less than 18 years,
• End organ failure as cardiac/ Liver/ Renal,
• Patients on home NIV and
• Those who required NIV for respiratory failure due to diseases other than COPD were not considered for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Gradual PS Decrement

Experimental group

Description:

): 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

Treatment:

Device: Noninvasive ventilation

Gradual Time Decrement

Experimental group

Description:

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.

Treatment:

Device: Noninvasive ventilation

Abrupt Withdrawal

Active Comparator group

Description:

patients will be immediately withdrawn from NIV and monitored on spontaneous breathing.

Treatment:

Device: Noninvasive ventilation