Ignite Creation Date:
2024-05-06 @ 12:14 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01523470
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2012-01-14
Brief Title:
Withdrawal of Non-invasive Ventilation in Chronic Obstructive Pulmonary Disease COPD Patients With Acute Hypercapnic Respiratory Failure
Sponsor:
United Christian Hospital
Organization:
United Christian Hospital
Study Overview
Official Title:
A Pilot Randomised Controlled Trial of Withdrawal of Non-invasive Ventilation in COPD Patients With Acute Hypercapnic Respiratory Failure
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators design a pilot randomised single-centred controlled trial to compare different withdrawal methods of Non-invasive ventilation Our study aims at comparing stepwise withdrawal of Non-invasive ventilation versus immediate withdrawal of Non-invasive ventilation The primary endpoint is to compare the rate of success between two withdrawal methods The investigators define success as no recurrence of acute hypercapnic respiratory failure or restitution of Non-invasive ventilation within 48 hours after NIV is stopped The secondary endpoints include time to recurrence of acute hypercapnic respiratory failure measured from the time of randomisation the total days of Non-invasive ventilation use and the days of hospitalisation Results from this trial will inform design of future randomised trial in this area
Detailed Description:
All patients would receive standard medical treatment with inhaled bronchodilator systemic steroid antibiotics according to our local bacteriology Acute NIV was initiated by trained respiratory nurses according to standardised protocols The nurses would be at the bedside during the initial acclimatization BIPAP vision was used to provide bi-level pressure support ventilation Interfacing with different types of nasal or full-mask would be individualised NIV was used for as many as possible in the first day at least 20 hrs Throughout the NIV treatment the following parameters will be monitored when NIV is started arterial blood gases respiratory rate heart rate and blood pressure mental state pulse oximetry If a patient failed to respond to NIV he or she would be intubated if appropriate Criteria for failure include lack of clinical improvement with increasing dyspnea and deterioration of blood gases hemodynamic instability uncontrolled ventricular arrythmia development of hypercapnic coma and cardiopulmonary arrest
A patient would be considered suitable to withdraw from the ventilator if he or she fulfil the criteria at rest
A patient would be considered suitable to withdraw from the ventilator if he or she fulfil the criteria at rest
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None