Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

This study has been completed.
Sponsor:
Collaborator:
Politecnico di Milano
Information provided by (Responsible Party):
Peter Kostic, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01474850
First received: November 8, 2011
Last updated: December 5, 2014
Last verified: December 2014

November 8, 2011
December 5, 2014
November 2011
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01474850 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.
Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography (OEP).
The aim of this study is to examine chest wall volume changes monitored by opto-electronic plethysmography during recovery from anesthesia and early postoperative period.

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:

  1. 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.
  2. 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Mechanical Ventilation
Procedure: lung recruitment maneuver
RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)
  • 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.
    Intervention: Procedure: lung recruitment maneuver
  • No Intervention: control
    No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration (FiO2) 100 % during recovery from anesthesia.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 years
  • ASA classification I-II, scheduled for elective surgery requiring general anesthesia
  • signed informed consent

Exclusion Criteria:

  • BMI > 35
  • co-existing respiratory disease (COPD, asthma )
  • patient refusal
  • pregnancy
  • deformities of the thorax
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01474850
Uppsala 2011 - 190
No
Not Provided
Not Provided
Peter Kostic, Uppsala University Hospital
Uppsala University Hospital
Politecnico di Milano
Principal Investigator: Peter Frykholm Uppsala University Hospital
Uppsala University Hospital
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP