Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

Not Applicable

Completed

• Conditions: Mechanical Ventilation
• Interventions: Procedure: lung recruitment maneuver

• Registration Number: NCT01474850
• Lead Sponsor: Uppsala University Hospital

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Primary Completion: 2012-06
• Study Completion: 2012-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open lung	lung recruitment maneuver	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.

Primary Outcome Measures

Name	Time	Method
Opto-electronic plethysmography (OEP)	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 Outcome Measures

Name	Time	Method
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)	5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation	Arterial blood gas measurement.

Trial Locations

Locations (1)

Uppsala University Hospital, Anesthesia and Intensive care dep.; 🇸🇪 Uppsala, Sweden