Thoraco-abdominal Volume Variations During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Uppsala University Hospital.
Recruitment status was  Recruiting
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: November 15, 2011
Last verified: November 2011

November 8, 2011
November 15, 2011
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 Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography
Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography.

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
General Anesthesia
  • Procedure: lung recruitment maneuver
    RM: peak inspiratory pressure 40 cmH2O, PEEP 7 cm H20, FiO2 0,4 (from end of surgery till extubation)
  • Procedure: No lung recruitment maneuver
    No RM, PEEP 0 cmH2O, FiO2 1,0 (from end of surgery till extubation)
  • Active Comparator: Lung recruitment maneuver
    The recruitment maneuver (RM) immediately after intubation using pressure controlled ventilation, increase in peak inspiratory pressure up to 40 cm H2O during tidal ventilation, respiratory rate 5/min and positive end expiratory pressure (PEEP) 7 cm H20. PEEP 7 cm H2O until extubation. Inspiratory oxygen concentration 40% during recovery from anesthesia.
    Intervention: Procedure: lung recruitment maneuver
  • No Intervention: No lung recruitment maneuver
    No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration 100 % during recovery from anesthesia.
    Intervention: Procedure: No lung recruitment maneuver
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
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
No
Contact: Peter Kostic +46186110000 peter.kostic@akademiska.se
Contact: Peter Frykholm +46186114824 peter.frykholm@akademiska.se
Sweden
 
NCT01474850
Uppsala 2011 - 190
Not Provided
Peter Kostic, Uppsala University Hospital
Uppsala University Hospital
Politecnico di Milano
Principal Investigator: Peter Frykholm Uppsala University Hospital
Uppsala University Hospital
November 2011

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