One Lung Ventillation (OLV)NCT01532245
The Use of Constant-flow Technique for Determining the Lower Inflexion Point of Pressure-volume Curve and Intrinsic PEEP During One-lung Ventilation
A study testing two lung ventilation (TLV), one lung ventilation (OLV) without PEEP and One lung ventilation (OLV) with positive end-expiratory pressure (PEEP) in people with One Lung Ventillation (OLV) and Two Lung Ventillation (TLV), run by The Cleveland Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One Lung Ventillation (OLV), Two Lung Ventillation (TLV), Positive End Expiratory Pressure (PEEP)
- What is being tested?
- two lung ventilation (TLV), one lung ventilation (OLV) without PEEP and One lung ventilation (OLV) with positive end-expiratory pressure (PEEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to 23 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- thoracic surgery lung ventillation
Who cannot join
None listed.
About this study
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)
- Being tested
- two lung ventilation (TLV), one lung ventilation (OLV) without PEEP, One lung ventilation (OLV) with positive end-expiratory pressure (PEEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two lung ventilation (TLV)Other
During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used.
one lung ventilation (OLV) without PEEPOther
During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated.
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
| Study group | Role | What they receive |
|---|---|---|
| two-lung ventilation (TLV) | Active comparator | During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used. Receives: 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. Receives: 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 Receives: Other: One lung ventilation (OLV) with positive end-expiratory pressure (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intrinsic positive end-expiratory pressure (PEEP) during ventillation
constant-flow method useful for determination of intrinsic positive end-expiratory pressure (PEEPi) during OLV
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startDec 2011
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Why it stopped: No participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One Lung Ventillation (OLV)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamás Végh,, M.D., Principal investigator, Klinikum Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532245
- Sponsor's protocol ID
- DEOEC RKEB/IKEB 3504-2011
- Status last verified
- Oct 2018
- First submitted
- 2 Feb 2012
- Last updated
- 25 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Constant-flow Technique for Determining the Lower Inflexion Point of Pressure-volume Curve and Intrinsic PEEP During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT01532245
- Acronym / sponsor ID
- DEOEC RKEB/IKEB 3504-2011
- Conditions
- One Lung Ventillation (OLV), Two Lung Ventillation (TLV), Positive End Expiratory Pressure (PEEP), Zero End-expiratory Pressure (ZEEP)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| two-lung ventilation (TLV) | Active comparator | Other: two lung ventilation (TLV)During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used. |
| one lung ventillation (OLV) without PEEP | Active comparator | Other: one lung ventilation (OLV) without PEEPDuring OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated. |
| one lung ventilation (OLV) with PEEP | Active comparator | Other: One lung ventilation (OLV) with positive end-expiratory pressure (PEEP)During OLV, ventilation periods of ten minutes, with and without 5 cmH2Opositive end-expiratory pressure (PEEP) were alternated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- thoracic surgery lung ventillation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| two lung ventilation (TLV)During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used. | Other | two-lung ventilation (TLV) |
| one lung ventilation (OLV) without PEEPDuring OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated. | Other | one lung ventillation (OLV) without PEEP |
| 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 | Other | one lung ventilation (OLV) with PEEP |
Primary outcome
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
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).
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)
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Related trials for One Lung Ventillation (OLV)
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Not yet recruitingObservational study
Right Ventricular Afterload Indices in Lung Surgery
Lung Cancer (Suspected or Confirmed), Thoracoscopic Lobectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamás Végh,, M.D. principal investigator
Klinikum Ludwigshafen
Questions about this trial
What is this clinical trial studying?
A study testing two lung ventilation (TLV), one lung ventilation (OLV) without PEEP and One lung ventilation (OLV) with positive end-expiratory pressure (PEEP) in people with One Lung Ventillation (OLV) and Two Lung Ventillation (TLV), run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intrinsic positive end-expiratory pressure (PEEP) during ventillation (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.