Pressure Support Ventilation With the Anesthetic Conserving Device

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Completed
CT.gov ID
NCT01017744
Collaborator
(none)
15
1
45
0.3

Study Details

Study Description

Brief Summary

Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation. These effects could be of interest in intensive care patients ventilated in pressure support ventilation mode. The purpose of this study is to evaluate mechanical respiratory effects of sevoflurane administered through a new specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®) in pressure support ventilation in intensive care patients. In fact, dead space and resistance generated by the device could cancel and even deteriorate the potential positive effects of sevoflurane on ventilation.

Condition or Disease Intervention/Treatment Phase
  • Device: Anesthetic Conserving Device
Phase 3

Detailed Description

Pharmacological sedation is often necessary in mechanical ventilated intubated patient. Since a little time, sevoflurane can be used in the intensive care unit via a specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®, SedanaMedical AB, Uppsala, Sweden) placed between the Y piece of the ventilatory circuit and the endotracheal tube. Sevoflurane is known to have ventilatory interesting effects such as bronchodilatation that can be useful in the treatment of severe asthma. These effects could be of interest in the intensive care ventilated patients. On the other hand, the AnaConDa® device could have negative influence on ventilatory mechanics caused by the increased dead space and the resistance to air flow. This negative effect with worsening of work of breathing (WOB) was demonstrated with classic heat and moister exchanger compared to heated humidifiers in pressure support ventilation (PSV). In this way, we would like to study the mechanical effects of the sevoflurane administered with the AnaConDa® compared to a classic management with a heated humidifier and sedation with intravenous remifentanil in PSV consecutive intensive care patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Respiratory Mechanical Effects of Sevoflurane Administered With the Anesthetic Conserving Device in Pressure Support Ventilation
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Work Of Breathing (WOB) measured during the last 5 minutes of the 20 minutes period of each treatment [during the last 5 minutes of the 20 minutes period of each treatment]

Secondary Outcome Measures

  1. Intrinsic positive end expiratory pressure (PEEPi), occlusion pressure (P0,1), peak expiratory resistance, respiratory rate, tidal volume, minute ventilation, death space volume. [in PSV consecutive intensive care patients]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults ICU patients who are no more in acute state, intubated and ventilated in pressure support ventilation with intravenous sedation by remifentanil, with light sedation (RASS -1 to -2).
Exclusion Criteria:
  • Respiratory distress.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Clermont-FERRAND Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Jean-Michel CONSTANTIN, General ICU, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01017744
Other Study ID Numbers:
  • CHU-0062
First Posted:
Nov 23, 2009
Last Update Posted:
Sep 4, 2013
Last Verified:
Sep 1, 2013

Study Results

No Results Posted as of Sep 4, 2013