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| ID | Type | Description | Link |
|---|---|---|---|
| PS050103 |
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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
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The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.
Hospital acquired pneumonia is a common and severe complication of Guillain Barré Syndrome. Several factors have been recognized as predictors of respiratory failure in adults with Guillain Barré Syndrome. They include a time from disease onset and patient admission of less seven days, inability to lift head, impaired swallowing and a forced vital capacity of less than 60% of predictive value. We reasonned that early mechanical ventilation may prevent aspiration which is likely the main cause of pneumonia in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Physiotherapy, oxygen as needed |
|
| 2 | Experimental | Mechanical ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mechanical ventilation | Procedure | Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hospital acquired pneumonia from randomization to study day 90 | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Time on a ventilator | Day 90 | |
| Intensive care unit lenght of stay | Day 90 | |
| Hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Djillali annane, MD, PhD | Raymond Poincaré Hospital, AP-HP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raymond Poincaré Hospital | Garches | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12545029 | Background | Sharshar T, Chevret S, Bourdain F, Raphael JC; French Cooperative Group on Plasma Exchange in Guillain-Barre Syndrome. Early predictors of mechanical ventilation in Guillain-Barre syndrome. Crit Care Med. 2003 Jan;31(1):278-83. doi: 10.1097/00003246-200301000-00044. | |
| 1928954 | Background | Chevrolet JC, Deleamont P. Repeated vital capacity measurements as predictive parameters for mechanical ventilation need and weaning success in the Guillain-Barre syndrome. Am Rev Respir Dis. 1991 Oct;144(4):814-8. doi: 10.1164/ajrccm/144.4.814. |
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| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
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| physiotherapy and oxygen if needed | Procedure | oxygen will be delivered via facial mask whenever needed and physiotherapy |
|
| Day 90 |
| Tolerance | Day 90 |
| 32997260 | Derived | Melone MA, Heming N, Meng P, Mompoint D, Aboab J, Clair B, Salomon J, Sharshar T, Orlikowski D, Chevret S, Annane D. Early mechanical ventilation in patients with Guillain-Barre syndrome at high risk of respiratory failure: a randomized trial. Ann Intensive Care. 2020 Sep 30;10(1):128. doi: 10.1186/s13613-020-00742-z. |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012138 |
| Respiratory Therapy |
| D012046 | Rehabilitation |