Individualized vs Low PEEP in One Lung Ventilation

The Effect of Individualized PEEP Compared to Low PEEP on Tissue Oxygenation During One Lung Ventilation in Obese Patients Undergoing Thoracic Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Diseases; Obesity; One-Lung Ventilation
• Intervention / Treatment: Procedure: One-lung ventilation with individualized PEEP; Procedure: One-lung ventilation with low PEEP

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral oximetry	Cerebral oximetry (a measure of oxygen levels in the brain) as measured by near-infrared spectroscopy (noninvasive monitor applied to the forehead)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood oxygen tension (PaO2)	A measure of oxygen level in arterial blood	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.
Venous blood oxygen tension (PvO2)	A measure of oxygen level in venous blood	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.
Venous blood oxygen saturation (SvO2)	A measure of oxygen saturation in venous blood	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.
Cardiac output	A measure of blood flow throughout the body	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.
Phenylephrine dose	Total dose of phenylephrine (medication used to raise blood pressure)	Total dose of phenylephrine administered during each intraoperative 20 minute experimental period. All measurements are made during the 4-6 hour surgery.

Collaborators and Investigators

• Sponsor: Dionne Peacher
• Investigators: Principal Investigator: Dionne Peacher, MD, University of Iowa

Publications and helpful links

General Publications

• Borges JB, Okamoto VN, Matos GF, Caramez MP, Arantes PR, Barros F, Souza CE, Victorino JA, Kacmarek RM, Barbas CS, Carvalho CR, Amato MB. Reversibility of lung collapse and hypoxemia in early acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Aug 1;174(3):268-78. doi: 10.1164/rccm.200506-976OC. Epub 2006 May 11.
• de Matos GF, Stanzani F, Passos RH, Fontana MF, Albaladejo R, Caserta RE, Santos DC, Borges JB, Amato MB, Barbas CS. How large is the lung recruitability in early acute respiratory distress syndrome: a prospective case series of patients monitored by computed tomography. Crit Care. 2012 Jan 8;16(1):R4. doi: 10.1186/cc10602.
• Campos JH, Feider A. Hypoxia During One-Lung Ventilation-A Review and Update. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2330-2338. doi: 10.1053/j.jvca.2017.12.026. Epub 2017 Dec 19. No abstract available.
• Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.
• Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
• Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2018
• Primary Completion (ACTUAL): May 19, 2021
• Study Completion (ACTUAL): May 19, 2021

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 201805831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
• IPD Sharing Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No