Condition category
Respiratory
Date applied
15/04/2005
Date assigned
18/04/2005
Last edited
13/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/16137351

Publication citations

  1. 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.

Additional files

Editorial Notes