Individualized vs Low PEEP in One Lung Ventilation

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03569774
• Other study ID #: 201805831
• Status: Withdrawn
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: May 19, 2021

Study information

• Verified date: July 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Obesity
• One-Lung Ventilation

Intervention

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

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Dionne Peacher

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Epub 2006 May 11. — View Citation

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. Review. — View Citation

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. — View Citation

Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García 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. — View Citation

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. Review. — View Citation

Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators, Cavalcanti AB, Suzumura ÉA, Laranjeira LN, Paisani DM, Damiani LP, Guimarães 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-Tascón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.