Intrapulmonary percussive ventilation (IPV) in acute exacerbations of chronic obstructive pulmonary disease (COPD) patients with mild respiratory acidosis: a randomised controlled trial

ISRCTN	ISRCTN17802078
DOI	https://doi.org/10.1186/ISRCTN17802078
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Frederic Vargas
Scientific

Pellegrin-Tripode Hospital
Bordeaux
33076
France

Email	frederic.vargas@chu-bordeaux.fr

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	The experimental protocol was approved by the institutional review board of the hospital
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2003
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	33
Key inclusion criteria	COPD patients in acute excerbations and respiratory acidosis with pH between 7.35 and 7.38
Key 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
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2004

Pellegrin-Tripode Hospital

Bordeaux
33076
France

Pellegrin-Tripode Hospital (France)
Hospital/treatment centre

Place Amelie Rabat Leon
Bordeaux
33076
France

Email	frederic.vargas@chu-bordeaux.fr
"ROR"	https://ror.org/02x581406

Other

Not provided at time of registration

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2005		Yes	No