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Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.

NCT ID: NCT01474850

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Mechanical Ventilation

Keywords

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mechanical ventilation pressure control ventilation lung recruitment positive end expiratory pressure opto-electronic plethysmography chest wall volume variation intravenous anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

lung recruitment maneuver

Intervention Type PROCEDURE

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

control

No recruitment maneuver is performed. PEEP 0 cm H2O. Inspiratory oxygen concentration (FiO2) 100 % during recovery from anesthesia.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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lung recruitment maneuver

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Politecnico di Milano

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter Kostic

Staff anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Frykholm

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Locations

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Uppsala University Hospital, Anesthesia and Intensive care dep.

Uppsala, Uppsala County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Uppsala 2011 - 190

Identifier Type: -

Identifier Source: org_study_id