CClinicalTrials.gg
CompletedNCT01474850Updated Dec 8, 2014

Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

An interventional study of lung recruitment maneuver in Mechanical Ventilation, sponsored by Uppsala University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-08.

Sponsored by Uppsala University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Mechanical Ventilation

Keywords

  • mechanical ventilation
  • pressure control ventilation
  • lung recruitment
  • positive end expiratory pressure
  • opto-electronic plethysmography
  • chest wall volume variation
  • intravenous anesthesia
03

In context

Lead sponsor

Uppsala University Hospital is the lead sponsor of 70 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • BMI > 35
  • co-existing respiratory disease (COPD, asthma )
  • patient refusal
  • pregnancy
  • deformities of the thorax
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • 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

  • No intervention
    control

    No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration (FiO2) 100 % during recovery from anesthesia.

Interventions

  • Procedurelung recruitment maneuver

    RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)

06

What researchers measure

Primary outcomes

  1. Opto-electronic plethysmography (OEP)

    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.

    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

Secondary outcomes

  1. 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

  2. Oxygenation (paO2)

    Arterial blood gas measurement.

    Time frame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation

07

Study locations

1 site
  • Uppsala University Hospital, Anesthesia and Intensive care dep.
    Uppsala, 751 85, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01474850
Lead sponsor
Uppsala University Hospital
Collaborators
Politecnico di Milano
Responsible party
Peter Kostic (Staff anesthesiologist, Uppsala University Hospital) — Principal investigator
First posted
Nov 18, 2011
Start date
Nov 2011
Primary completion
Jun 2012
Completion
Nov 2012
Last update
Dec 8, 2014

Study contacts

Peter Frykholm
principal investigator · Uppsala University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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