NCT01506284

Brief Summary

The aims of the present study are:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 9, 2014

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

December 9, 2011

Last Update Submit

December 8, 2014

Conditions

Keywords

Forced oscillatory techniqueLaser interferometryIntravenous anesthesiaMechanical ventilationPressure controlled ventilationAirways mechanical propertiesRespiratory system reactanceOscillatory mechanicsAtelectasis

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and 5 minutes of ventilation

Secondary Outcomes (3)

  • Change in chest wall displacement measured by LIR

    baseline and 5 minutes of ventilation

  • Change in oxygenation (paO2)

    baseline and 5 minutes of ventilation

  • Change in Functional residual capacity (FRC)

    baseline and 5 minutes of ventilation

Study Arms (1)

Anesthetized patients ASA I-II

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

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

Interventions

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.

Anesthetized patients ASA I-II

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hopsital, Dep. of Anesthesia and Intensive Care

Uppsala, Uppsala County, 751 85, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 19789855BACKGROUND
  • 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.

    PMID: 21455750BACKGROUND
  • 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.

    PMID: 21575220BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Peter Frykholm, MD, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 9, 2011

First Posted

January 9, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

November 1, 2012

Last Updated

December 9, 2014

Record last verified: 2012-01

Locations