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Number of Patients:
Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) = 20
Inclusion criteria
a) Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no indication for invasive mechanical ventilation.
Exclusion criteria
Control(s): Patients receiving pressure support ventilation (NIV-PSV) will act as control
Study design: Randomized interventional study
Dosages of drug: None
Duration of treatment: Till patient improves or requires invasive ventilation.
Brief Methodology Patients of COPD with acute exacerbation will be randomized into two groups (group A and group B) to receive NIV-PSV or NIV-NAVA respectively. A special naso-gastric catheter (EAdi-catheter) will be placed in all patients. In each mode, NIV will be applied using a non-vented oro-nasal mask that will be fitted enough to avoid air leaks. Patients in Group A will receive NIV-PS and Group B will receive ventilation via NIV-NAVA. Pressure support and PEEP levels will be set by the treating physician to achieve a tidal volume (Vt) of 6 to 8 mL/kg of ideal body weight. NAVA level will be adjusted to match peak pressures of NIV-PSV using manufacturer-supplied software. After stabilization, a 30-min period of each NIV trial will be recorded and manually analyzed offline. Subsequent readings will be taken at 2, 6 and at 24 hours and then at 6 hourly interval from day 2 onwards. In each trial, patient-ventilator asynchronies (ineffective efforts, auto triggering, premature cycling, delayed cycling, and double triggering) will be determined on EAdi, airway pressure, and flow signal. The number of each type of asynchrony, defined as the number of events per minute, will be determined for each recording period. The asynchrony index (AI), in percentage, will be calculated as described previously, and an AI >10% will be considered severe asynchrony. Patient comfort level after each mode of ventilation will be assessed by using visual analogue scale. Various clinical, ventilatory and arterial blood gas parameters will be recorded.
Statistical analysis Data will be expressed as mean ± standard deviation (SD), or percentage. Differences in continuous variables between the two groups will be compared using student's t test (or Mann-Whitney U test); while differences in categorical data will be compared using the chi- square test (or Fisher's exact test). A p value of less than 0.05 will be considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurally adjusted ventilator assist | Experimental | Neurally adjusted ventilator assist (NAVA) during NIV for exacerbation of COPD. |
|
| Pressure support ventilation | Active Comparator | Pressure support ventilation (PSV) during NIV for exacerbation of COPD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurally Adjusted Ventilator Assist | Device | NAVA during Non-invasive ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the number of patient ventilator asynchrony | To assess the difference of number of patient ventilator asynchrony | Entire period of ventilatory support, an average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in rate of NIV failure | To assess the difference of rate of NIV failure | Entire hospital stay, an average of 7 days |
| Difference in total duration of ventilatory support | To assess the difference in total duration of ventilatory support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vijay Hadda, MD | AIIMS, New Delhi, INDIA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIIMS | New Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31641071 | Derived | Tajamul S, Hadda V, Madan K, Tiwari P, Mittal S, Khan MA, Mohan A, Guleria R. Neurally-Adjusted Ventilatory Assist Versus Noninvasive Pressure Support Ventilation in COPD Exacerbation: The NAVA-NICE Trial. Respir Care. 2020 Jan;65(1):53-61. doi: 10.4187/respcare.07122. Epub 2019 Oct 22. |
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Will share, if required
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Pressure support ventilation | Device | PS during Non-invasive ventilation |
|
|
| Entire hospital stay, an average of 7 days |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |