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Non-invasive mechanical ventilation with average volume assured pressure support (AVAPS) in hypercapnic encephalopathy
ISRCTN ISRCTN05135218
DOI 10.1186/ISRCTN05135218
ClinicalTrials.gov identifier
EudraCT number
Public title Non-invasive mechanical ventilation with average volume assured pressure support (AVAPS) in hypercapnic encephalopathy
Scientific title Non-invasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy: prospective interventional match-controlled study
Acronym N/A
Serial number at source 1857461069795800
Study hypothesis To determine if the use of BiPAP S/T with AVAPS as the first line of noninvasive ventilatory treatment in patients with exacerbations of Chronic obstructive pulmonary disease (COPD) and hypercapnic encephalopathy (GCS < 10), is useful and safe.
Lay summary Lay summary under review 2
Ethics approval School of Medicine Ethics Committee of the Universidad San Francisco de Quito, 03 January 2009, ref: 3012009
Study design Prospective interventional match-controlled study
Countries of recruitment Ecuador
Disease/condition/study domain Infectious exacerbations of COPD and hypercapnic encephalopathy
Participants - inclusion criteria 1. Age > 40 years
2. COPD was diagnosed on the basis of the recommendations of the American Thoracic Society
3. Hypercapnic encephalopathy with GCS < 10 were designated to receive BiPAP S/T with AVAPS
4. The control group was then selected from patients in the emergency unit with infectious exacerbations of COPD and encephalopathy (GCS < 10). Patients were treated immediately and referred to us by doctors who were unaware of the study. Each patient was treated with NIV and was selected according to: Acute Physiology and Chronic Health Evaluation II (APACHE II) score within 4 points, age within 10 points, pH within 0.04, GCS within 2 points, and BMI within 2 points
5. Informed consent
Participants - exclusion criteria 1. A face deformity
2. Obstruction of the upper respiratory tract owing to recent surgery or trauma
3. Alterations in the central nervous system not related to a hypercapnic encephalopathy
4. Cardiogenic pulmonary edema, pneumothorax, pulmonary thromboembolism, hemoptysis, or septic shock
5. Urgent intubation owing to cardiac and/or respiratory arrest, and hemodynamic instability with a systolic arterial blood pressure (BP) of less than 80mmH
6. Other neurological illness
Anticipated start date 01/02/2009
Anticipated end date 01/09/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 11 x 2
Interventions 11 patients with infectious exacerbations of COPD and hypercapnic encephalopathy with GCS < 10 were designated to receive BiPAP S/T with AVAPS.

The control group was then selected from patients in the emergency unit with infectious exacerbations of COPD and encephalopathy (GCS < 10).
Primary outcome measure(s) Level of consciousness (Glasgow Coma Scale score)
Secondary outcome measure(s) 1. Duration of mechanical ventilation
2. Hospital stay, and
3. Progression (exhaled tidal volume, inspiratory pressure, and arterial blood gases)
Sources of funding Universidad San Francisco de Quito (Ecuador)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23497021
Contact name Dr  Killen  Briones Claudett
  Address Geraneos II Mz 3010 Villa 7
  City/town Guayaquil
  Zip/Postcode 5934
  Country Ecuador
  Tel +593 4 289 3242
  Email kyllenbrio@yahoo.com
Sponsor San Francisco de Quito University (Universidad San Francisco de Quito) (Ecuador)
  Address c/o Dr Killen Harold Briones Claudett
School of Medicine
  City/town Guayaquil
  Zip/Postcode 5934
  Country Ecuador
  Email kyllenbrio@yahoo.com
Date applied 07/09/2012
Last edited 19/03/2013
Date ISRCTN assigned 18/09/2012
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