Chronic Obstructive Pulmonary Disease Clinical Trial
— PSV vs ASV forVerified date | January 2018 |
Source | Postgraduate Institute of Medical Education and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The clinical course of chronic obstructive pulmonary disease (COPD) is associated with recurrent episodes of exacerbation that results in respiratory failure. The treatment of respiratory failure is supportive and involves inhalation bronchodilators along with systemic steroids. In few cases the management of acute respiratory failure requires positive pressure ventilation (non-invasive or invasive). The use of NIV in acute exacerbation of COPD has resulted in significant reduction in morbidity and mortality. Although pressure support ventilation (PSV) allows the patient to influence the breathing pattern, ventilator-cycling criteria may worsen the patient-ventilator interaction, and severe asynchronies occur in up to 43% of patients undergoing NIV for ARF. Adaptive support ventilation (ASV) is a newer mode of ventilation that incorporates feedback mechanisms and thus provides a stable minute ventilation. We hypothesize that the use of ASV as a mode during ventilation using NIV in patients with acute exacerbation of COPD may result in reducing the duration of ventilatory support, need for intubation, and duration of intensive care unit (ICU) and hospital length of stay, when compared with PSV mode of NIV ventilation.
Status | Completed |
Enrollment | 74 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: All consecutive patients with acute exacerbation of COPD will be assessed for inclusion in the current study. The diagnosis of acute exacerbation of COPD will be made based on following criteria: 1. an acute sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity and/or character, dyspnea) that is beyond normal day today variation and leads to a change in medication 2. arterial blood gas analysis showing a PaCO2>45 mm of Hg with either pH <7.35 =7.26 or respiratory rate >30/minute 3. exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax. Exclusion Criteria: Patients with any one of the following criteria will be excluded from the current study: 1. non-COPD acute hyper-capneic respiratory failure. 2. hypotension (systolic blood pressure<90mmHg), 3. severe encephalopathy (Glasgow coma scale score < 8), 4. upper gastrointestinal bleeding 5. inability to protect the airway and clear respiratory secretions, or abnormalities that preclude proper fit of the interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality). 6. patients who are on home NIV. 7. failure to give consent. |
Country | Name | City | State |
---|---|---|---|
India | Respiratory ICU, Post Graduate Institue of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in the rate of NIV success | To assess the difference in the rate of NIV success using either PSV or ASV mode of ventilation | 28 days after discharge | |
Secondary | Patient comfort | Assess patient comfort using VAS score | 28 days after discharge | |
Secondary | Duration of mechanical ventilation | Duration of mechanical ventilation (both non-invasive and invasive) | 28 days after discharge | |
Secondary | Time to weaning | Total time to wean from positive airway pressure ventilation | 28 days after discharge | |
Secondary | ICU and hospital length of stay | Total duration of hospital and intensive care unit stay | 28 days after discharge |
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