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
  Purpose

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.


Condition Intervention
General Anesthesia
Procedure: lung recruitment maneuver
Procedure: No lung recruitment maneuver

Study Type: Interventional
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.

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 14
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: lung recruitment maneuver
RM: peak inspiratory pressure 40 cmH2O, PEEP 7 cm H20, FiO2 0,4 (from end of surgery till extubation)
No Intervention: No lung recruitment maneuver
No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration 100 % during recovery from anesthesia.
Procedure: No lung recruitment maneuver
No RM, PEEP 0 cmH2O, FiO2 1,0 (from end of surgery till extubation)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474850

Contacts
Contact: Peter Kostic +46186110000 peter.kostic@akademiska.se
Contact: Peter Frykholm +46186114824 peter.frykholm@akademiska.se

Locations
Sweden
Uppsala University Hospital, Anesthesia and Intensive care dep. Recruiting
Uppsala, Sweden, 751 85
Contact: Peter Kostic, MD    +46186110000    peter.kostic@akademiska.se   
Contact: Peter Frykholm, MD,PhD    +46186114824    peter.frykholm@akademiska.se   
Sponsors and Collaborators
Uppsala University Hospital
Politecnico di Milano
Investigators
Principal Investigator: Peter Frykholm Uppsala University Hospital
  More Information

No publications provided

Responsible Party: Peter Kostic, Staff anesthesiologist, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01474850     History of Changes
Other Study ID Numbers: Uppsala 2011 - 190
Study First Received: November 8, 2011
Last Updated: November 15, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University Hospital:
mechanical ventilation
pressure control ventilation
lung recruitment
positive end expiratory pressure
opto-electronic plethysmography
chest wall volume variation
intravenous anesthesia

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014