AnesthesiaNCT01506284
Assessment of Airways Mechanical Properties by FOT and LIR During Anesthesia
An observational study of Anesthesia, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Forced oscillatory technique (FOT) and laser interferometry (LIR).
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ASA classification I-II, scheduled for elective surgery requiring general anesthesia
Who may be able to join
- age >18 years
- ASA I-II, scheduled for elective surgery requiring general anesthesia
- signed informed consent
Who cannot join
- patient refusal
- BMI > 35
- co-existing respiratory disease (COPD, asthma, restrictive lung disease)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Uppsala University Hopsital, Dep. of Anesthesia and Intensive Care
Uppsala, Uppsala County, 751 85
About this study
Official title: 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
Read the 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)
- Conditions
- Anesthesia
- Being tested
- Forced oscillatory technique (FOT) and laser interferometry (LIR).
- Keywords
- Forced oscillatory technique, Laser interferometry, Intravenous anesthesia, Mechanical ventilation, Pressure controlled ventilation, Airways mechanical properties, Respiratory system reactance, Oscillatory mechanics, Atelectasis
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced oscillatory technique (FOT) and laser interferometry (LIR).Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Anesthetized patients ASA I-II | ASA classification I-II, scheduled for elective surgery requiring general anesthesia. Receives: Procedure: Forced oscillatory technique (FOT) and laser interferometry (LIR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory system impedance
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.
Measured: baseline and 5 minutes of ventilation
Secondary outcomes (3)
Change in chest wall displacement measured by LIR
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.
Measured: baseline and 5 minutes of ventilation
Change in oxygenation (paO2)
Arterial blood gas measurement (ABG)
Measured: baseline and 5 minutes of ventilation
Change in Functional residual capacity (FRC)
Measured: baseline and 5 minutes of ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Principal investigator, Peter Kostic, Uppsala University Hospital
- Investigators
- Peter Frykholm, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506284
- Sponsor's protocol ID
- Uppsala 2011 - 189
- Status last verified
- Jan 2012
- First submitted
- 9 Dec 2011
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19789855Dellaca 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.
PubMed 21455750Kostic 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.
PubMed 21575220
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Airways Mechanical Properties by Forced Oscillatory Technique (FOT) and Laser Interferometry (LIR) During Anesthesia.
- ClinicalTrials.gov ID
- NCT01506284
- Acronym / sponsor ID
- Uppsala 2011 - 189
- Conditions
- Anesthesia
- Keywords
- Forced oscillatory technique, Laser interferometry, Intravenous anesthesia, Mechanical ventilation, Pressure controlled ventilation, Airways mechanical properties, Respiratory system reactance, Oscillatory mechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthetized patients ASA I-II | – | Procedure: Forced oscillatory technique (FOT) and laser interferometry (LIR).ASA classification I-II, scheduled for elective surgery requiring general anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ASA classification I-II, scheduled for elective surgery requiring general anesthesia
Key inclusion criteria (3 listed)
- age >18 years
- ASA I-II, scheduled for elective surgery requiring general anesthesia
- signed informed consent
Key exclusion criteria (4 listed)
- patient refusal
- BMI > 35
- co-existing respiratory disease (COPD, asthma, restrictive lung disease)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced oscillatory technique (FOT) and laser interferometry (LIR).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. | Procedure or surgery | Anesthetized patients ASA I-II |
Primary outcome
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.
3 secondary outcomes
Change in chest wall displacement measured by LIR
Time frame: baseline and 5 minutes of ventilation
Change in oxygenation (paO2)
Time frame: baseline and 5 minutes of ventilation
Change in Functional residual capacity (FRC)
Time frame: baseline and 5 minutes of ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Background: PubMed 19789855Dellaca 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.
- Background: PubMed 21455750Dellaca 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.
- Background: PubMed 21575220Kostic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Frykholm, MD, PhD principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in respiratory system impedance (time frame: baseline and 5 minutes of ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01506284, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.