Assessment of Oxygen Delivery as an Early Predictor of Postoperative Pulmonary Complications During One-lung Pulmonary Ventilation in Thoracic Surgery. A Pilot Study

Study Overview
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Brief Summary
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This is a simple descriptive pilot study where 60 patients undergoing One-lung ventilation (OLV) for > 120 minutes during esophagectomy will be enrolled to see if the Flo Trac® system can identify hypoxemia earlier than the standard of care monitoring.

Detailed Description
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One-lung ventilation (OLV) is necessary to facilitate surgical exposure in thoracic surgery. OLV can lead to hypoxemia due to the collapse of the non-dependent lung with potentially increased atelectasis in the dependent lung. Hypoxemia, the low oxygen level in the blood, during OLV can be detected by a decrease in arterial hemoglobin oxygen saturation (SaO2) measured by pulse oximetry (SpO2%). Although the incidence of hypoxemia during OLV is currently considered less than 4%, SaO2 is not well correlated to the oxygen supply to the tissues, determined by oxygen delivery (DO2), thus normal values of SaO2 can be associated with abnormal values of DO2 and on the contrary, hypoxemic values of SaO2 can be associated with normal values of DO2. Hypoxemia in patients with cardiovascular, cerebrovascular and/or pulmonary disease leads to an increased risk of complications related to low oxygen supply. Postoperative pulmonary complications (POPCs) can lead to increased perioperative morbidity and mortality, increased incidence of admission to an intensive care unit, prolonged hospital stay and increased medical cost. To the best of our knowledge, there are no studies in thoracic surgery, including esophagectomies, where intraoperative Oxygen Delivery (DO2) or DO2 index (DO2i) is used as a strategy for early detection of POPCs. There are also no studies that have determined the critical level of DO2 and DO2i or Percentage of Oxygen Extraction (O2ER) and Percentage of Oxygen Extraction index (O2ERi) in thoracic surgery associated with POPCs. The aim of this study is to determine if the use of DO2 and DO2i as a continuous non-invasive monitor of oxygen supply to the tissues during OLV, may help us determine the critical DO2 and DO2i to predict POPCs.

Official Title
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Assessment of Oxygen Delivery as an Early Predictor of Postoperative Pulmonary Complications During One-lung Pulmonary Ventilation in Thoracic Surgery. A Pilot Study

Conditions
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Postoperative Pulmonary Complications

Intervention / Treatment
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* Diagnostic Test: Standard surgical monitoring, along with the Flo Trac® system monitoring.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years Esophagectomy surgery requiring one-lung ventilation for > 120 minutes Exclusion Criteria: Severe heart disease (LVEF (Left ventricle ejection fraction) <50%) and/or Heart failure with CI (cardiac index) <2.5 l/min/m2 or need of vasopressors and/or ionotropic support Genetic alterations of hemoglobin Pregnant patients History of severe restrictive lung disease (such as pulmonary fibrosis with minimal FEV1 of <75% or COPD/emphysema with minimal FEV1 of <50%) which may affect inflation/deflation times Trauma patients requiring VATS/thoracotomy Patient with recent mechanical ventilation support (2 weeks)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard surgical monitoring, along with the Flo Trac® system monitoring.<br> | Diagnostic Test: Standard surgical monitoring, along with the Flo Trac® system monitoring.<br>* Under standard thoracic anesthesia protocol, extra monitoring will be done by FloTrac® System using a minimally invasive sensor in combination with an advanced monitoring device to derive cardiac output (CO) and cardiac index (CI) parameters through arterial pulse pressure waveform analysis. Intraoperative blood gases collection will be at different intraoperative times. From this data, calculations will be performed to obtain DO2, DO2i, O2ER, and O2ERi.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the occurrence of any POPCs within 30 days of surgery. |  | 30 days from the day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen delivery, Thoracic surgery, One-lung pulmonary ventilation