- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01506284
Assessment of Airways Mechanical Properties by FOT and LIR During Anesthesia
Assessment of Airways Mechanical Properties by Forced Oscillatory Technique (FOT) and Laser Interferometry (LIR) During Anesthesia.
The aims of the present study are:
- To evaluate the effect of the induction of anaesthesia and paralysis in terms of changes in oscillatory mechanics parameters
- To evaluate the mechanical properties of the respiratory system in terms of input and transfer oscillatory impedance in response to PEEP changes
Study Overview
Status
Conditions
Intervention / Treatment
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
- 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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Uppsala, Sweden, 751 85
- Uppsala University Hopsital, Dep. of Anesthesia and Intensive Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Publications and helpful links
General Publications
- Dellaca RL, Andersson Olerud M, Zannin E, Kostic P, Pompilio PP, Hedenstierna G, Pedotti A, Frykholm P. Lung recruitment assessed by total respiratory system input reactance. Intensive Care Med. 2009 Dec;35(12):2164-72. doi: 10.1007/s00134-009-1673-3. Epub 2009 Sep 30.
- Dellaca RL, Zannin E, Kostic P, Olerud MA, Pompilio PP, Hedenstierna G, Pedotti A, Frykholm P. Optimisation of positive end-expiratory pressure by forced oscillation technique in a lavage model of acute lung injury. Intensive Care Med. 2011 Jun;37(6):1021-30. doi: 10.1007/s00134-011-2211-7. Epub 2011 Apr 1.
- Kostic P, Zannin E, Andersson Olerud M, Pompilio PP, Hedenstierna G, Pedotti A, Larsson A, Frykholm P, Dellaca RL. Positive end-expiratory pressure optimization with forced oscillation technique reduces ventilator induced lung injury: a controlled experimental study in pigs with saline lavage lung injury. Crit Care. 2011;15(3):R126. doi: 10.1186/cc10236. Epub 2011 Apr 28.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Uppsala 2011 - 189
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.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University Health Network, TorontoActive, not recruiting
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
Ankara City Hospital BilkentCompletedAnesthesia | Sedation | Anesthesia, Intravenous | Sedation Complication | Recovery From Anesthesia | Monitoring of Depth of AnesthesiaTurkey (Türkiye)
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
University of ChicagoWithdrawnAnesthesia | Patient Satisfaction | Anesthesia Risks | Anesthesia Consent | Consent RetentionUnited States
Clinical Trials on Forced oscillatory technique (FOT) and laser interferometry (LIR).
-
Rambam Health Care CampusUnknownAsthma in ChildrenIsrael
-
University Children's Hospital BaselRecruitingPositive End-expiratory Pressure (PEEP)Switzerland
-
Imperial College LondonRoyal Brompton & Harefield NHS Foundation Trust; Action Medical Research; Masonic...Recruiting
-
The Hospital for Sick ChildrenDalhousie UniversityCompletedAsthma | Obstructive Sleep Apnea | Food Allergy | Virus | WheezeCanada
-
University of NottinghamRecruiting