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Completed

NCT Number: NCT01017744

Pressure Support Ventilation With the Anesthetic Conserving Device

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Clermont-FERRAND

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anesthetic Conserving Device

Device
  • Ventilation in PSV with the Anesthetic Conserving Device with remifentanil
  • Ventilation in PSV with the Anesthetic Conserving Device with sevoflurane

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Respiratory Mechanical Effects of Sevoflurane Administered With the Anesthetic Conserving Device in Pressure Support Ventilation

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 23, 2009
Registry last updated
Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.