Thoraco-abdominal Volume Variations During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography

This study is currently recruiting participants.

Verified November 2011 by Uppsala University Hospital

Sponsor:

Collaborator:

Politecnico di Milano

Information provided by (Responsible Party):

Peter Kostic, Uppsala University Hospital

ClinicalTrials.gov Identifier:

NCT01474850

First received: November 8, 2011

Last updated: November 15, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2011

Last Updated Date

November 15, 2011

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01474850 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Oxygenation (paO2) [ Time Frame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation ] [ Designated as safety issue: No ]
Arterial blood gas measurement.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Thoraco-abdominal Volume Variations During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography

Official Title ^ICMJE

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

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:

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

General Anesthesia

Intervention ^ICMJE

Procedure: lung recruitment maneuver
RM: peak inspiratory pressure 40 cmH2O, PEEP 7 cm H20, FiO2 0,4 (from end of surgery till extubation)
Procedure: No lung recruitment maneuver
No RM, PEEP 0 cmH2O, FiO2 1,0 (from end of surgery till extubation)

Study Arm (s)

Active Comparator: Lung recruitment maneuver
The recruitment maneuver (RM) immediately after intubation using pressure controlled ventilation, increase in peak inspiratory pressure up to 40 cm H2O during tidal ventilation, respiratory rate 5/min and positive end expiratory pressure (PEEP) 7 cm H20. PEEP 7 cm H2O until extubation. Inspiratory oxygen concentration 40% during recovery from anesthesia.

Intervention: Procedure: lung recruitment maneuver
No Intervention: No lung recruitment maneuver
No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration 100 % during recovery from anesthesia.

Intervention: Procedure: No lung recruitment maneuver

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Peter Kostic	+46186110000	peter.kostic@akademiska.se
Contact: Peter Frykholm	+46186114824	peter.frykholm@akademiska.se

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01474850

Other Study ID Numbers ^ICMJE

Uppsala 2011 - 190

Has Data Monitoring Committee

Not Provided

Responsible Party

Peter Kostic, Uppsala University Hospital

Study Sponsor ^ICMJE

Uppsala University Hospital

Collaborators ^ICMJE

Politecnico di Milano

Investigators ^ICMJE

Principal Investigator:

Peter Frykholm

Uppsala University Hospital

Information Provided By

Uppsala University Hospital

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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