Condition category
Respiratory
Date applied
07/09/2012
Date assigned
18/09/2012
Last edited
19/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Killen Briones Claudett

ORCID ID

Contact details

Geraneos II Mz 3010 Villa 7
Guayaquil
5934
Ecuador
+593 4 289 3242
kyllenbrio@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1857461069795800

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infectious exacerbations of COPD and hypercapnic encephalopathy

Intervention

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).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Level of consciousness (Glasgow Coma Scale score)

Secondary outcome measures

1. Duration of mechanical ventilation
2. Hospital stay, and
3. Progression (exhaled tidal volume, inspiratory pressure, and arterial blood gases)

Overall trial start date

01/02/2009

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

11 x 2

Participant 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

Recruitment start date

01/02/2009

Recruitment end date

01/09/2011

Locations

Countries of recruitment

Ecuador

Trial participating centre

Geraneos II Mz 3010 Villa 7
Guayaquil
5934
Ecuador

Sponsor information

Organisation

San Francisco de Quito University (Universidad San Francisco de Quito) (Ecuador)

Sponsor details

c/o Dr Killen Harold Briones Claudett
School of Medicine
Guayaquil
5934
Ecuador
kyllenbrio@yahoo.com

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Universidad San Francisco de Quito (Ecuador)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23497021

Publication citations

  1. Results

    Briones Claudett KH, Briones Claudett M, Chung Sang Wong M, Nuques Martinez A, Soto Espinoza R, Montalvo M, Esquinas Rodriguez A, Gonzalez Diaz G, Grunauer Andrade M, Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy., BMC Pulm Med, 2013, 13, 12, doi: 10.1186/1471-2466-13-12.

Additional files

Editorial Notes