Contact information
Type
Scientific
Primary contact
Dr Frederic Vargas
ORCID ID
Contact details
Pellegrin-Tripode Hospital
Bordeaux
33076
France
frederic.vargas@chu-bordeaux.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
We hypothesised that the use of intrapulmonary percussive ventilation (IPV), a technique designed to improve mucus clearance, could prove effective in avoiding further deterioration in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) with mild respiratory acidosis.
Ethics approval
The experimental protocol was approved by the institutional review board of the hospital
Study design
Randomised controlled trial
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
Acute exacerbations of chronic obstructive pulmonary disease (COPD) patients with mild respiratory acidosis
Intervention
Comparison of two groups of COPD:
1. A standard goup: COPD patients with standard treatment alone
2. An IPV group: COPD patients with standard treatment plus IPV
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Therapy was considered to be successful when it enabled the avoidance of both a worsening of the exacerbation and a decrease in pH to under 7.35 (which would have required NIV), and allowed the patient to be discharged from the ICU.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
COPD patients in acute excerbations and respiratory acidosis with pH between 7.35 and 7.38
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
33
Participant exclusion criteria
1. The requirement for emergency intubation for cardiopulmonary resuscitation, respiratory arrest, or in the case of rapid deterioration in neurological status (Glasgow coma scale inferior or equal to 8)
2. Hemodynamic instability defined as a systolic blood pressure of less than 80 mmHg or evidence on electrocardiography of ischemia or clinically significant ventricular arrhythmias
3. Failure of more than two additional organs; or tracheotomy, pneumothorax, facial deformity, or a recent history of oral, oesophageal or gastric surgery
Recruitment start date
01/01/2003
Recruitment end date
31/12/2004
Locations
Countries of recruitment
France
Trial participating centre
Pellegrin-Tripode Hospital
Bordeaux
33076
France
Sponsor information
Organisation
Pellegrin-Tripode Hospital (France)
Sponsor details
Place Amelie Rabat Leon
Bordeaux
33076
France
frederic.vargas@chu-bordeaux.fr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Not provided at time of registration
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
Basic results (scientific)
Publication list
2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/16137351
Publication citations
-
Results
Vargas F, Bui HN, Boyer A, Salmi LR, Gbikpi-Benissan G, Guenard H, Gruson D, Hilbert G, Intrapulmonary percussive ventilation in acute exacerbations of COPD patients with mild respiratory acidosis: a randomized controlled trial [ISRCTN17802078]., Crit Care, 2005, 9, 4, R382-9, doi: 10.1186/cc3724.