- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532245
The Use of Constant-flow Technique for Determining the Lower Inflexion Point of Pressure-volume Curve and Intrinsic PEEP During One-lung Ventilation
One method for treating intraoperative hypoxia during one-lung ventilation (OLV) is application of PEEP to the dependent lung. However, only a minority of patients benefit from this maneuver. The effect of applied PEEP on oxygenation depends on the relation between the total end-expiratory pressure and the lower inflexion point (LIP) of pressure-volume curve (1). LIP during OLV can be determined with super-syringe technique, but is too complicated for routine operating room use. An alternative is the constant-flow method which is easy and widely used in intensive care settings (2). The investigators goal was to confirm that the constant-flow method as applied by an intensive care ventilator works during OLV.
Methods: After IRB approval and written, informed consent, data were obtained from 20 patients during OLV for thoracic surgery who were ventilated with an AVEA (VIASYS Healthcare) critical-care ventilator. During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used. During OLV, ventilation periods of ten minutes, with and without 5 cmH2O PEEP were alternated. During each period, the investigators recorded arterial blood partial pressures, respiratory and hemodynamic values, intrinsic PEEP (PEEPi), and LIP. PEEPi and LIP were determined using the automatic mode of the ventilator; specifically, LIP was determined with a continuous flow of 3L/minute.
Study Overview
Status
Conditions
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- thoracic surgery lung ventillation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: two-lung ventilation (TLV)
During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used.
|
During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used.
|
Active Comparator: one lung ventillation (OLV) without PEEP
During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated.
|
During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated.
|
Active Comparator: one lung ventilation (OLV) with PEEP
During OLV, ventilation periods of ten minutes, with and without 5 cmH2Opositive end-expiratory pressure (PEEP) were alternated
|
During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intrinsic positive end-expiratory pressure (PEEP) during ventillation
Time Frame: 10 minutes
|
constant-flow method useful for determination of intrinsic positive end-expiratory pressure (PEEPi) during OLV
|
10 minutes
|
lower inflexion point (LIP) of P-V curve during one lung ventillation (OLV)
Time Frame: 10 minutes
|
constant-low method useful for determination of lower inflexion point (LIP) of P-V curve during one lung ventillation (OLV).
|
10 minutes
|
net change of Lower Inflexion Point (LIP)- intrinsic positive end-expiratory pressure (PEEPi) ditstance with PEEP
Time Frame: 10 minutes
|
Relationship between the net change of lower inflexion point (LIP)- positive end-expiratory pressure (PEEPi) ditstance with and without positive end-expiratory pressure (PEEP) and change of PaO2 is useful during OLV for determination of patients reaction for application extternal positive end-expiratory pressure (PEEP)
|
10 minutes
|
net change of lower inflexion point (LIP)-PEEPi ditstance without PEEP
Time Frame: 10 minutes
|
Relationship between the net change of lower inflexion point (LIP)-intrinsic positive end-expiratory pressure (PEEPi) ditstance with and without positive end-expiratory pressure (PEEP) and change of PaO2 is useful during one lung ventillation (OLV) for determination of patients reaction for application external positive end-expiratory pressure (PEEP).
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tamás Végh,, M.D., Klinikum Ludwigshafen
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DEOEC RKEB/IKEB 3504-2011
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