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

NCT01532245 | Withdrawn

• 1 other identifier: DEOEC RKEB/IKEB 3504-2011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

One Lung Ventillation (OLV); Two Lung Ventillation (TLV); Positive End Expiratory Pressure (PEEP); Zero End-expiratory Pressure (ZEEP)

Outcome Measures

Primary Outcomes (4)

• intrinsic positive end-expiratory pressure (PEEP) during ventillation

  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)

  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

  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

  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

Study Arms (3)

two-lung ventilation (TLV)

ACTIVE COMPARATOR

During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used.

Other: two lung ventilation (TLV)

one lung ventillation (OLV) without PEEP

ACTIVE COMPARATOR

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

one lung ventilation (OLV) with PEEP

ACTIVE COMPARATOR

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)

Interventions

two lung ventilation (TLV) OTHER

During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used.

two-lung ventilation (TLV)

one lung ventilation (OLV) without PEEP OTHER

During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated.

one lung ventillation (OLV) without PEEP

One lung ventilation (OLV) with positive end-expiratory pressure (PEEP) OTHER

During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated

one lung ventilation (OLV) with PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• thoracic surgery lung ventillation

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Interventions

One-Lung Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics

Study Officials

• Tamás Végh,, M.D.

  Klinikum Ludwigshafen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 14, 2012
• Study Start: December 1, 2011
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: October 25, 2018

Record last verified: 2018-10