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The Use of Constant-flow Technique for Determining the Lower Inflexion Point of Pressure-volume Curve and Intrinsic PEEP During One-lung Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01532245
First received: February 2, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
One Lung Ventillation (OLV)
Two Lung Ventillation (TLV)
Positive End Expiratory Pressure (PEEP)
Zero End-expiratory Pressure (ZEEP)
Other: two lung ventilation (TLV)
Other: one lung ventilation (OLV) without PEEP
Other: One lung ventilation (OLV) with positive end-expiratory pressure (PEEP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • intrinsic positive end-expiratory pressure (PEEP) during ventillation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    constant-flow method useful for determination of intrinsic positive end-expiratory pressure (PEEPi) during OLV

  • lower inflexion point (LIP) of P-V curve during one lung ventillation (OLV) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    constant-low method useful for determination of lower inflexion point (LIP) of P-V curve during one lung ventillation (OLV).

  • net change of Lower Inflexion Point (LIP)- intrinsic positive end-expiratory pressure (PEEPi) ditstance with PEEP [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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)

  • net change of lower inflexion point (LIP)-PEEPi ditstance without PEEP [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: two-lung ventilation (TLV)
During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used.
Other: two lung ventilation (TLV)
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.
Other: one lung ventilation (OLV) without PEEP
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
Other: One lung ventilation (OLV) with positive end-expiratory pressure (PEEP)
During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • thoracic surgery lung ventillation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532245

Contacts
Contact: Tamás Végh,, M.D. 36-52-255-347 veghdr@gmail.com

Locations
Hungary
University of Debrecen, Medical and Health Science CenterDepartment of Anesthesiology and Intensive Care Recruiting
Debrecen, Hungary
Contact: Tamás Végh, M.D.    36-52-255-347    veghdr@gmail.com   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Tamás Végh,, M.D. Klinikum Ludwigshafen
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01532245     History of Changes
Other Study ID Numbers: DEOEC RKEB/IKEB 3504-2011
Study First Received: February 2, 2012
Last Updated: September 10, 2012
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee

ClinicalTrials.gov processed this record on November 27, 2014