Assessment of Airways Mechanical Properties by FOT and LIR During Anesthesia

December 8, 2014 updated by: Peter Kostic, Uppsala University Hospital

Assessment of Airways Mechanical Properties by Forced Oscillatory Technique (FOT) and Laser Interferometry (LIR) During Anesthesia.

The aims of the present study are:

  1. To evaluate the effect of the induction of anaesthesia and paralysis in terms of changes in oscillatory mechanics parameters
  2. To evaluate the mechanical properties of the respiratory system in terms of input and transfer oscillatory impedance in response to PEEP changes

Study Overview

Detailed Description

It has been recently shown that respiratory system reactance (Xrs) obtained by the forced oscillation technique (FOT) at 5 Hz is more reliable than dynamic compliance for assessing lung collapse and the effects of lung RMs in a porcine ALI model ( Ref.1,2).

Specifically, Xrs (and its derived variable CX5, the oscillatory compliance at 5 Hz) identifies the minimum positive end-expiratory pressure (PEEP) level required to maintain lung recruitment with high sensitivity and specificity. Moreover, it has been recently demonstrated that Xrs may be used to identify the lowest level of PEEP able to prevent atelectasis and that PEEP setting strategy based on maximizing Xrs is able to limit lung injury compared to oxygenation-based approach in a porcine lavage model of lung injury. ( Ref.3)

Recently, at the biomedical engineering department of Politecnico di Milano measurements of chest wall displacement have been successfully performed by means of an optical sensor realized using a laser self-mixing interferometer (LIR). The advantage of this approach is that it is contact-less, that by deflecting the laser been it is possible to scan any region of the chest wall surface and that it allows to measure also low-frequency vibrations.

Protocol

  1. The baseline pulmonary function will be assessed by spirometry before surgery.
  2. Just before surgery measurements of oscillatory mechanics will be performed at the following stages:

    • awake patient
    • spontaneous ventilation through the laryngeal mask after induction of anesthesia
    • pressure controlled ventilation (PCV) after the administration of neuromuscular blocking agent and intubation and PEEP 0 cmH2O
    • PCV with PEEP 5 cmH2O
    • Recruitment maneuver (RM) (peak pressure 30 cmH2O and PEEP 15 cmH2O) for 2 minutes
    • PCV with PEEP 5 cmH2O after RM

At each stage the following measurements will be performed:

  • Input impedance at 5-11-19 Hz by FOT
  • the movements of the chest wall assessed by laser interferometry (LIR) applying two different stimulating waveforms: 5-11-19 Hz and 100 Hz
  • functional residual capacity (FRC)
  • arterial blood gas measurement (ABG)

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Uppsala, Sweden, 751 85
        • Uppsala University Hopsital, Dep. of Anesthesia and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients ASA classification I-II, scheduled for elective surgery requiring general anesthesia

Description

Inclusion Criteria:

  • age >18 years
  • ASA I-II, scheduled for elective surgery requiring general anesthesia
  • signed informed consent

Exclusion Criteria:

  • patient refusal
  • BMI > 35
  • co-existing respiratory disease (COPD, asthma, restrictive lung disease)
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anesthetized patients ASA I-II
ASA classification I-II, scheduled for elective surgery requiring general anesthesia.

FOT: The stimulating signal is generated by an A/D-D/A board and amplified by a power amplifier that drives a loudspeaker the output of which is connected to inspiratory line of the ventilator. Pressure and flow are measured at the inlet of the endotracheal tube by a piezoresistive pressure transducer and a mesh-type heated pneumotachograph coupled with a differential pressure transducer.

LIR: The scanner unit is made by three laser interferometers, the beams of which are deflected on the chest wall surface by a mirror moved by a stepper motor triggered on the respiratory pattern of patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in respiratory system impedance
Time Frame: baseline and 5 minutes of ventilation

FOT measurements:

Respiratory system impedance will be computed from the flow and pressure signals measured at the inlet of the tracheal tube. A composite waveform including 5, 11 and 19 Hz will be used as a stimulating signal generated by an A/D-D/A board and amplified by a power amplifier that drives a loudspeaker the output of which is connected to inspiratory line of the ventilator.

baseline and 5 minutes of ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in chest wall displacement measured by LIR
Time Frame: baseline and 5 minutes of ventilation

Laser interferometry (LIR):

The movement of 18 points of the chest wall will be measured by a self-mixing interferometer. The measurement points will be chosen along three vertical lines (the midline and the two parasternal lines) and will be equally distributed from the clavicles to the anterior superior iliac spines. The chest wall movement will be measured in response to two different stimulating waveforms: a composite waveform including 5, 11 and 19 Hz, a sinusoidal signal at 100 Hz.

baseline and 5 minutes of ventilation
Change in oxygenation (paO2)
Time Frame: baseline and 5 minutes of ventilation
Arterial blood gas measurement (ABG)
baseline and 5 minutes of ventilation
Change in Functional residual capacity (FRC)
Time Frame: baseline and 5 minutes of ventilation
baseline and 5 minutes of ventilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

December 9, 2011

First Submitted That Met QC Criteria

January 4, 2012

First Posted (ESTIMATE)

January 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

January 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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