Postoperative Pulmonary ComplicationsDO2 and POPCsNCT05154617
Assessment of Oxygen Delivery as an Early Predictor of Postoperative Pulmonary Complications During One-lung Pulmonary Ventilation in Thoracic Surgery. A Pilot Study
A study testing Standard surgical monitoring, along with the Flo Trac® system monitoring. in people with Postoperative Pulmonary Complications, run by University Health Network, Toronto.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications
- What is being tested?
- Standard surgical monitoring, along with the Flo Trac® system monitoring.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Esophagectomy surgery requiring one-lung ventilation for > 120 minutes
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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.
- Conditions
- Postoperative Pulmonary Complications
- Being tested
- Standard surgical monitoring, along with the Flo Trac® system monitoring.
- Keywords
- Thoracic surgery, Oxygen delivery, One-lung pulmonary ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard surgical monitoring, along with the Flo Trac® system monitoring.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard surgical monitoring, along with the Flo Trac® system monitoring. | Other | Not described Receives: Diagnostic Test: Standard surgical monitoring, along with the Flo Trac® system monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the occurrence of any POPCs within 30 days of surgery.
Measured: 30 days from the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacobo Moreno Garijo, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154617
- Sponsor's protocol ID
- 21-5094
- Acronym
- DO2 and POPCs
- Status last verified
- Aug 2021
- First submitted
- 25 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Oxygen Delivery as an Early Predictor of Postoperative Pulmonary Complications During One-lung Pulmonary Ventilation in Thoracic Surgery. A Pilot Study
- ClinicalTrials.gov ID
- NCT05154617
- Acronym / sponsor ID
- DO2 and POPCs / 21-5094
- Conditions
- Postoperative Pulmonary Complications
- Keywords
- Thoracic surgery, Oxygen delivery, One-lung pulmonary ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard surgical monitoring, along with the Flo Trac® system monitoring. | Other | Diagnostic Test: Standard surgical monitoring, along with the Flo Trac® system monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥ 18 years
- Esophagectomy surgery requiring one-lung ventilation for > 120 minutes
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard surgical monitoring, along with the Flo Trac® system monitoring.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. | Diagnostic test | Standard surgical monitoring, along with the Flo Trac® system monitoring. |
Primary outcome
The primary outcome will be the occurrence of any POPCs within 30 days of surgery.
Time frame: 30 days from the day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobo Moreno Garijo, MD principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Standard surgical monitoring, along with the Flo Trac® system monitoring. in people with Postoperative Pulmonary Complications, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacobo Moreno Garijo, MD ((416) 340-4800 ext. 3472, Jacobo.Moreno@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the occurrence of any POPCs within 30 days of surgery. (time frame: 30 days from the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.