Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography (OEP).|
- Opto-electronic plethysmography (OEP) [ Time Frame: 1. 5 min after each of these steps: the onset of the mechanical ventilation, the randomization, the end of the surgery 2. continuously during recovery 3. one hour after extubation ] [ Designated as safety issue: No ]Respiratory movements and thoracic and abdominal volume changes is recorded continuously using OEP (OEP system, BTS,Milan, Italy) by analysing the movements of retro-reflective markers using six video cameras connected to an automatic optoelectronic motion analyser.
- Functional residual capacity (FRC) [ Time Frame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the sergery ] [ Designated as safety issue: No ]
- Oxygenation (paO2) [ Time Frame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation ] [ Designated as safety issue: No ]Arterial blood gas measurement.
|Study Start Date:||November 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: open lung
The lung recruitment maneuver (RM) immediately after intubation using pressure controlled ventilation, increase in peak inspiratory pressure up to 30 cm H2O during tidal ventilation, respiratory rate 4/min and positive end expiratory pressure (PEEP) 15 cm H20. PEEP 7 cm H2O until extubation. Inspiratory oxygen concentration (FiO2) 40% during recovery from anesthesia.
Procedure: lung recruitment maneuver
RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)
No Intervention: control
No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration (FiO2) 100 % during recovery from anesthesia.
This is prospective, randomized clinical trial in subjects undergoing elective surgery requiring general anesthesia.
Opto-electronic plethysmography (OEP) has been developed as a non-invasive method for the analysis of chest wall motion, allowing highly accurate measurements of chest wall volume changes of different respiratory compartments in various conditions.
The investigators set out to use this technology to study chest wall volume changes during recovery from total intravenous anesthesia (from discontinuing the anesthetic agent till extubation) and early postoperative period.
The study protocol compares two different approaches:
- The group receiving recruitment maneuver (RM) immediately after intubation and positive end expiratory pressure (PEEP) 7 cm H20 until extubation. Inspiratory oxygen concentration 40% during recovery from anesthesia.
- The group not receiving RM, PEEP 0 cm H2O and inspiratory oxygen concentration 100% during recovery from anesthesia.
The volume changes of the chest wall is monitored continuously by OEP, functional residual capacity (FRC) and arterial oxygenation are measured at the defined points in the protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474850
|Uppsala University Hospital, Anesthesia and Intensive care dep.|
|Uppsala, Sweden, 751 85|
|Principal Investigator:||Peter Frykholm||Uppsala University Hospital|