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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Procedure: lung recruitment maneuver

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)
NO_INTERVENTION: control; No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration (FiO2) 100 % during recovery from anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional residual capacity (FRC)		5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the sergery
Oxygenation (paO2)	Arterial blood gas measurement.	5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation

Collaborators and Investigators

• Sponsor: Uppsala University Hospital
• Collaborators: Politecnico di Milano
• Investigators: Principal Investigator: Peter Frykholm, Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: November 8, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (ESTIMATE): November 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: mechanical ventilation; positive end expiratory pressure; intravenous anesthesia; lung recruitment; pressure control ventilation; opto-electronic plethysmography; chest wall volume variation
• Other Study ID Numbers: Uppsala 2011 - 190