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

October 23, 2018 updated by: The Cleveland Clinic

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

Status

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Withdrawn

Conditions

Conditions

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Intervention / Treatment

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Study Type

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Interventional

Phase

Phase

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  • Not Applicable

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • thoracic surgery lung ventillation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tamás Végh,, M.D., Klinikum Ludwigshafen

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

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December 1, 2011

Primary Completion (Actual)

Primary Completion

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October 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2012

First Posted (Estimate)

First Posted

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February 14, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEOEC RKEB/IKEB 3504-2011

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