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Individualized vs Low PEEP in One Lung Ventilation

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ClinicalTrials.gov Identifier: NCT03569774
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dionne Peacher, University of Iowa

Brief Summary:
The aim of the prospective crossover study is to investigate the effect of individualized positive end-expiratory pressure (PEEP) on measures of tissue oxygenation, compared with low PEEP.

Condition or disease Intervention/treatment Phase
One-Lung Ventilation Obesity Lung Diseases Procedure: One-lung ventilation with individualized PEEP Procedure: One-lung ventilation with low PEEP Not Applicable

Detailed Description:

During surgery on the lung, ventilation of one lung at a time is often necessary. During thoracic surgery requiring one-lung ventilation (OLV), hypoxemia (reduced oxygen tension in blood) can present a clinical challenge. Due to multiple factors, the likelihood of hypoxemia during OLV in obese patients is increased. Atelectasis (collapse of the lung airspaces) contributes to hypoxemia and can be mitigated by application of recruitment maneuvers and positive end-expiratory pressure (PEEP). A recruitment maneuver is a breath given in a mechanically ventilated patient that helps to open up collapsed air spaces, and PEEP is application of a continuous amount of positive pressure that helps keep the air spaces open at the end of an exhaled breath. Adjusting the level of PEEP to each individual patient's optimal lung compliance (individualized PEEP) improves blood oxygen levels compared to application of standard low PEEP (5 cmH2O); however, higher levels of PEEP required to achieve optimal lung compliance could increase intrathoracic pressures to a level that impedes normal circulation. This could negatively affect blood flow (cardiac output) and delivery of oxgyen to vital organs.

Evidence addressing OLV in obese patients is lacking. The purpose of this study is to compare brain oxygen levels (cerebral oxygen saturation) and measures of blood flow and gas exchange during OLV with individualized PEEP vs low standard PEEP in obese patients undergoing thoracic surgery. To our knowledge, there is no previous study that compares oxygen delivery to vital organs (such as the brain) during OLV using individualized PEEP versus standard low PEEP, in an obese patient population.

In this study, subjects undergoing OLV during surgery to remove a portion of the lung (lobectomy) will undergo a process to determine their individualized PEEP and then two 20-minute experimental periods-- one period with OLV with low PEEP and one period with OLV with individualized PEEP. Measurements of cerebral oxygen saturation, blood oxygen levels, cardiac output, and blood pressure medication dose will be measuring before and after these experimental periods during surgery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Mechanical ventilation with individualized PEEP will be compared to mechanical ventilating with low PEEP during lung isolation in each subject. Each subject will receive one PEEP level then will receive the second PEEP level. The order in which each subject receives the PEEP level will be randomized.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Individualized PEEP Compared to Low PEEP on Tissue Oxygenation During One Lung Ventilation in Obese Patients Undergoing Thoracic Surgery
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021

Arm Intervention/treatment
Experimental: Individualized PEEP
Individualized PEEP will be identified by performing a decremental PEEP protocol which will determine the level of PEEP that correlates with maximal lung compliance in each subject. Subjects will receive one-lung ventilation with individualized PEEP
Procedure: One-lung ventilation with individualized PEEP
During one-lung ventilation for lung resection surgery, PEEP will be applied. After a subject's individualized PEEP (PEEP that corresponds to maximum lung compliance) is determined, the subject will receive one-lung ventilation with individualized PEEP.

Active Comparator: Low PEEP
Subjects will receive One-lung ventilation with low PEEP (5 cmH2O)
Procedure: One-lung ventilation with low PEEP
Subjects will receive one-lung ventilation with low PEEP (5 cmH2O)




Primary Outcome Measures :
  1. Cerebral oximetry [ Time Frame: Change from baseline cerebral oximetry at the end of each intraoperative 20 minute experimental period. All measurements are made during the 4-6 hour surgery. ]
    Cerebral oximetry (a measure of oxygen levels in the brain) as measured by near-infrared spectroscopy (noninvasive monitor applied to the forehead)


Secondary Outcome Measures :
  1. Arterial blood oxygen tension (PaO2) [ Time Frame: Measured at baseline, and then at the end of each 20 minute intraoperative experimental period. All measurements are made during the 4-6 hour surgery. ]
    A measure of oxygen level in arterial blood

  2. Venous blood oxygen tension (PvO2) [ Time Frame: Measured at baseline, and then at the end of each 20 minute intraoperative experimental period. All measurements are made during the 4-6 hour surgery. ]
    A measure of oxygen level in venous blood

  3. Venous blood oxygen saturation (SvO2) [ Time Frame: Measured at baseline, and then at the end of each 20 minute intraoperative experimental period. All measurements are made during the 4-6 hour surgery. ]
    A measure of oxygen saturation in venous blood

  4. Cardiac output [ Time Frame: Measured at baseline, and then at the end of each 20 minute intraoperative experimental period. All measurements are made during the 4-6 hour surgery. ]
    A measure of blood flow throughout the body

  5. Phenylephrine dose [ Time Frame: Total dose of phenylephrine administered during each intraoperative 20 minute experimental period. All measurements are made during the 4-6 hour surgery. ]
    Total dose of phenylephrine (medication used to raise blood pressure)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject undergoing elective pulmonary lobectomy requiring one-lung ventilation
  2. Body-mass index ≥ 30 kg/m2
  3. Age ≥ 18 years and ≤ 80 years

Exclusion Criteria:

  1. Age ≤ 18 year or ≥ 80 years
  2. Moderate or severe cardiac valvular disease
  3. Left ventricular ejection fraction < 30%
  4. Moderate or severe right ventricular systolic dysfunction
  5. Severe pulmonary hypertension
  6. Presence of pulmonary bullae or blebs on preoperative chest imaging studies (e.g., radiograph, computed tomograph)
  7. Emergency surgery
  8. Previous history of lung surgery on the non-operative lung
  9. Pregnancy
  10. Incarceration
  11. Mental incapacitation
  12. Patient refusal
  13. Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569774


Contacts
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Contact: Dionne Peacher, MD 319-467-6793 dionne-peacher@uiowa.edu
Contact: Alicia Manning 319-353-8040 alicia-manning@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Dionne Peacher, MD    319-467-6793    dionne-peacher@uiowa.edu   
Principal Investigator: Dionne Peacher, MD         
Sponsors and Collaborators
Dionne Peacher
Investigators
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Principal Investigator: Dionne Peacher, MD University of Iowa

Publications:

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Responsible Party: Dionne Peacher, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03569774     History of Changes
Other Study ID Numbers: 201805831
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases