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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.
A study to compare protocolized weaning from non-invasive ventilation using three potential strategies of weaning from NIV
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gradual PS Decrement | Experimental | ): 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4 cm of H2O is attained, after which NIV will be completely withdrawn |
|
| Gradual Time Decrement | Experimental | 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. |
|
| Abrupt Withdrawal | Active Comparator | patients will be immediately withdrawn from NIV and monitored on spontaneous breathing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive ventilation | Device | Weaning from noninvasive ventilation for patients with acute exacerbation of COPD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful weaning | The primary objective of the study is to compare the rate of successful withdrawal of NIV among the three groups. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| waleed gamal elddin, ass. prof | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University hospital | Asyut | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26976648 | Background | Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/Intensive Care Society Acute Hypercapnic Respiratory Failure Guideline Development Group, On behalf of the British Thoracic Society Standards of Care Committee. BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Thorax. 2016 Apr;71 Suppl 2:ii1-35. doi: 10.1136/thoraxjnl-2015-208209. No abstract available. | |
| 23490403 |
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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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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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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.
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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
| Background |
| Lun CT, Chan VL, Leung WS, Cheung AP, Cheng SL, Tsui MS, Chu CM. A pilot randomized study comparing two methods of non-invasive ventilation withdrawal after acute respiratory failure in chronic obstructive pulmonary disease. Respirology. 2013 Jul;18(5):814-9. doi: 10.1111/resp.12080. |
| 7921460 | Background | Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |