Clinical trial NCT01474850: Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.
Official title: Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography (OEP).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: mechanical ventilation
pressure control ventilation
lung recruitment
positive end expiratory pressure
opto-electronic plethysmography
chest wall volume variation
intravenous anesthesia
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2011-11-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Opto-electronic plethysmography (OEP)
timeFrame: 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:
measure: Functional residual capacity (FRC)
timeFrame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the sergery
measure: Oxygenation (paO2)
timeFrame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Anesthesia and Intensive care dep.
Study officials:
affiliation: Uppsala University Hospital
name: Peter Frykholm
role: PRINCIPAL_INVESTIGATOR
References: