Condition category
Respiratory
Date applied
20/07/2005
Date assigned
20/07/2005
Last edited
25/09/2009
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

Prof Dimitris Georgopoulos

ORCID ID

Contact details

ICU
University Hospital of Heraklion
Heraklion
Crete
711 10
Greece
georgop@med.uoc.gr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The aim of our study was to examine the influence of controlled and assisted modes of ventilatory support on the bronchodilative effect induced by b2-agonists administered with a metered-dose inhaler (MDI) and a spacer in a homogeneous group of patients with acute exacerbation of chronic obstructive pulmonary disease.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute exacerbation of chronic obstructive pulmonary disease

Intervention

All patients were intubated with an endotracheal tube 8-9 mm in internal diameter, sedated (propofol and remifentanyl) and initially ventilated (for 24 to 36 hours) on volume-controlled (VC) mode using settings that minimized dynamic hyperinflation. After this period, the patients were switched to flow-triggering pressure-support (PS) ventilation with the level of pressure assist adjusted to obtain a tidal volume (VT) of 7-10 ml/kg. Extrinsic positive end-expiratory pressure (PEEP) of approximately 1-2 cmH2O lower than PEEPi, measured on controlled mode, was applied. The threshold for triggering was set to 2 l/min. Propofol and remifentanyl infusions during VC and PS mode were titrated such as to obtain sedation levels 6 and 3 on the Ramsey scale respectively. If patients were stable on PS with adequate gas exchange, respiratory frequency less than 30 breaths/min and without clinical evidence of excessive work of breathing, all bronchodilators were withheld for 6 hours. By the end of this period patients were re-evaluated and if they had a respiratory frequency of less than 30 breaths/min, adequate gas exchange and no clinical evidence of excessive work of breathing they were prospectively randomized to receive 4 puffs of salbutamol (S, 100 µg/puff given by an MDI canister, Aerolin inhaler, GlaxoWellcome) being ventilated either on PS or VC mode. On VC mode, VT and ventilator frequency were set to values similar to these on PS. A square wave flow pattern was used and no end-inspiratory pause time was applied. No manipulation was performed on PS. After a six hour washout-period, the patients were crossed-over to receive the drug by the alternative mode of ventilation. The MDI was adapted to the inspiratory limb of the ventilator circuit using an aerosol cloud enhancer spacer (ACE, Diemolding Healthcare Division, USA), whereby the MDI flume is directed away from the patient. The spacer was placed just before the Y-ventilator connector. The canister was shaken before each series of puffs. Each actuation was performed at 20 to 30 sec intervals, immediately before initiation of airflow by the ventilator on VC or before the sudden drop in airway pressure on PS, which signaled the start of the triggering process. Arterial blood gases were measured before and 4 hours after drug administration. SaO2 was measured continuously using a pulse oxymeter (Critikon, Tampa, FLA, USA).

Intervention type

Drug

Phase

Not Specified

Drug names

Salbutamol

Primary outcome measures

Respiratory system mechanics (Resistance)

Secondary outcome measures

Heart rate, arterial blood gasses

Overall trial start date

01/03/2003

Overall trial end date

01/11/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with chronic obstructive pulmonary disease (COPD), requiring endotracheal intubation and mechanical ventilation to manage acute respiratory failure due to an acute exacerbation of chronic airflow obstruction, were studied. All patients had a previous diagnosis of COPD and met established criteria for this diagnosis.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Hemodynamically unstable

Recruitment start date

01/03/2003

Recruitment end date

01/11/2003

Locations

Countries of recruitment

Greece

Trial participating centre

ICU
Heraklion, Crete
711 10
Greece

Sponsor information

Organisation

University of Crete, Medical School (Greece)

Sponsor details

Voutes
Heraklion
Crete
711 10
Greece
root@danae.med.uoc.gr

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

None

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/16774821

Publication citations

  1. Results

    Malliotakis P, Mouloudi E, Prinianakis G, Kondili E, Georgopoulos D, Influence of respiratory efforts on b2-agonist induced bronchodilation in mechanically ventilated COPD patients: a prospective clinical study., Respir Med, 2007, 101, 2, 300-307, doi: 10.1016/j.rmed.2006.05.002.

Additional files

Editorial Notes