Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Noninvasive ventilation, Weaning
Brief summary
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.
Detailed 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.
Interventions
DEVICENoninvasive ventilation
Weaning from noninvasive ventilation for patients with acute exacerbation of COPD
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful weaning | 48 hours | The primary objective of the study is to compare the rate of successful withdrawal of NIV among the three groups. |
Countries
Egypt
Outcome results
None listed