Pressure Support Ventilation With the Anesthetic Conserving Device
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
-
Device: Anesthetic Conserving Device
- Ventilation in PSV with the Anesthetic Conserving Device with remifentanil
- Ventilation in PSV with the Anesthetic Conserving Device with sevoflurane
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 |
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| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| France | |
| CHU Clermont-FERRAND | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
| Principal Investigator: | Jean-Michel CONSTANTIN, General ICU | University Hospital, Clermont-Ferrand |
More Information
Publications:
| Responsible Party: | Patrick LACARIN, CHU Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01017744 History of Changes |
| Other Study ID Numbers: | CHU-0062 |
| Study First Received: | November 20, 2009 |
| Last Updated: | January 18, 2011 |
| 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 Sevoflurane Remifentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Platelet Aggregation Inhibitors |
Hematologic Agents Anesthetics, Inhalation Anesthetics, General Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous |
ClinicalTrials.gov processed this record on May 23, 2013