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Pressure Support Ventilation With the Anesthetic Conserving Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01017744
First received: November 20, 2009
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Intensive Care Ventilation
Device: Anesthetic Conserving Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Respiratory Mechanical Effects of Sevoflurane Administered With the Anesthetic Conserving Device in Pressure Support Ventilation

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Work Of Breathing (WOB) measured during the last 5 minutes of the 20 minutes period of each treatment [ Time Frame: during the last 5 minutes of the 20 minutes period of each treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intrinsic positive end expiratory pressure (PEEPi), occlusion pressure (P0,1), peak expiratory resistance, respiratory rate, tidal volume, minute ventilation, death space volume. [ Time Frame: in PSV consecutive intensive care patients ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: November 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Anesthetic Conserving Device
    • Ventilation in PSV with the Anesthetic Conserving Device with remifentanil
    • Ventilation in PSV with the Anesthetic Conserving Device with sevoflurane
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017744

Locations
France
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
  More Information

Publications:
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01017744     History of Changes
Other Study ID Numbers: CHU-0062
Study First Received: November 20, 2009
Last Updated: September 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Anesthetic Conserving Device
Anaconda®
Sevoflurane
Remifentanil
Sedation
Pressure support ventilation
Work of breathing
Intrinsic positive end expiratory pressure
Ventilatory dead space
Intensive care
Weaning of mechanical ventilation
Ventilated ICU patients in PSV
No more in acute state
No respiratory distress
Sedated by intravenous remifentanil
In light sedation as define by a Richmond Agitation Sedation Scale (RASS) of - 1 to - 2.

Additional relevant MeSH terms:
Anesthetics
Remifentanil
Sevoflurane
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014