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Completed

NCT Number: NCT01474850

Thoraco-abdominal Volume Variations During Anesthesia Studied by 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.

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Key information

Conditions

Mechanical Ventilation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, Anesthesia and Intensive care dep.

Uppsala, Uppsala County, 751 85, Sweden

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung recruitment maneuver

Procedure

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

Primary outcomes

  1. 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

    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 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)

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

    Arterial blood gas measurement.

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Politecnico di Milano

Registry information

Official study title

Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography (OEP).

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 18, 2011
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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