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Completed

NCT Number: NCT01506284

Assessment of Airways Mechanical Properties by FOT and 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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University Hopsital, Dep. of Anesthesia and Intensive Care

Uppsala, Uppsala County, 751 85, Sweden

About this study

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

  • The baseline pulmonary function will be assessed by spirometry before surgery.
  • 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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Forced oscillatory technique (FOT) and laser interferometry (LIR).

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in oxygenation (paO2)

    Time frame: baseline and 5 minutes of ventilation

    Arterial blood gas measurement (ABG)

  3. Change in Functional residual capacity (FRC)

    Time frame: baseline and 5 minutes of ventilation

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Politecnico di Milano

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2012
Registry last updated
Dec 9, 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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