Individualized vs Low PEEP in One Lung Ventilation

NCT03569774 | Withdrawn DMC

• 1 other identifier: 201805831
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

One-Lung Ventilation; Obesity; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Arterial blood oxygen tension (PaO2)

  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)

  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)

  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

  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 administered during each intraoperative 20 minute experimental period. All measurements are made during the 4-6 hour surgery.

Study Arms (2)

Individualized PEEP

EXPERIMENTAL

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

Low PEEP

ACTIVE COMPARATOR

Subjects will receive One-lung ventilation with low PEEP (5 cmH2O)

Procedure: One-lung ventilation with low PEEP

Interventions

One-lung ventilation with individualized PEEP PROCEDURE

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.

Individualized PEEP

One-lung ventilation with low PEEP PROCEDURE

Subjects will receive one-lung ventilation with low PEEP (5 cmH2O)

Low PEEP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dionne Peacher: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (6)

• 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.

  PMID: 29361458 BACKGROUND

• 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.

  PMID: 19417615 BACKGROUND

• 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.

  PMID: 24557111 BACKGROUND

• 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.

  PMID: 22226331 BACKGROUND

• 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.

  PMID: 16690982 BACKGROUND

• 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.

  PMID: 28973363 BACKGROUND

MeSH Terms

Conditions

Obesity; Lung Diseases

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics

Study Officials

• Dionne Peacher, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: June 26, 2018
• Study Start: August 14, 2018
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (1)