One-Lung VentilationOLVinFACHIRNCT02959515
The Effects of Different Types of Non-ventilated Lung Management on DO2 During OLV in the Supine Position
A study testing Capnothorax and Capnothorax and CPAP in people with One-Lung Ventilation and Thoracic Surgery Video Assisted, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and OLV+capnothorax and CPAP. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- One-Lung Ventilation, Thoracic Surgery Video Assisted, Supine Position
- What is being tested?
- Capnothorax and Capnothorax and CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to Apr 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pts electively subjected to OLV in supine position for VATS ablation of AF and requiring OLV for > 30'
Who cannot join
- Expected difficult positioning of DLT, severe obesity BMI > 35, uncompensated cardiac disease. OLV < 30'.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, 20138
Luca salvi, MD, +39 02 58002 ext. 541, luca.salvi@ccfm.it
About this study
Official title: The Effects of Different Methods of Non-ventilated Lung Management on Oxygen Delivery (DO2) During One Lung Ventilation (OLV) in the Supine Position for Video Assisted Thoracoscopic (VATS) Atrial Fibrillation Ablation
The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and OLV+capnothorax and CPAP.
Read the detailed description
One-lung ventilation (OLV) is utilized mainly during thoracic procedures when surgeon needs the lung deflated to expose the surgical field. In this situation both lungs are perfused but only one is ventilated resulting in high grade of shunt and eventually hypoxemia .
Most of thoracic procedures are performed with the pt lying on one side; the deflated lung receive less blood flow both for the gravity and for the hypoxic pulmonary vasoconstriction (HPV) thus reducing the shunt.
If the pt lyes supine, as in VATS atrial fibrillation (AF) surgical ablation, the protective effect of gravity is lost, shunt remains high and severe hypoxemia is common. Some algorithms are used to improve oxygenation during OLV: high fraction of inspired oxygen (FiO2), positive end expiratory pressure (PEEP) on the ventilated lung, continuous positive airway pressure (CPAP) on the deflated lung, but the latter can be used with caution during VATS because of the obstruction of the surgical field. Increasing the pressure in the pleural cavity with carbon dioxyde (CO2) (capnothorax) could decrease the blood flow in the deflated lung, helping in reducing shunt but this is not yet demonstrated and this manouver could decrease cardiac output. The oxygen delivery (DO2) is cardiac output (CO) by oxygen content and during this surgery both these factors could be compromised.
All consecutive pts electively subjected to OLV in supine position for VATS ablation of AF will be enrolled. On the day of surgery pts will be randomly allocated in two groups depending on the management of the non-ventilated lung (capnothorax or capnothorax and CPAP.
Pts in supine position; tracheal intubation with left-sided double lumen tube (DLT) and position confirmed by bronchoscopy. Lungs are initially ventilated with pressure controlled mode (PCV) at a tidal volume (TV) of 7 mL/kg, I:E ratio 1:2, respiratory rate (RR) to obtain a PaCO2 40-45 mmHg, FiO2 =1 and PEEP 5 cm H2O. During OLV inspiratory pressure is reduced to obtain a TV of 5 mL/Kg, maintaining FiO2=1, PEEP 5 cm H2O and adjusting RR to obtain a PaCO2 40-45 mmHg. Capnothorax is obtained by the insufflation of CO2 and maintained at a preset pressure of 10 mmHg. CPAP on the non ventilated lung is set at 10 cm H2O and FiO2=1.
After institution of OLV pts will be randomized to receive capnothorax alone (Group CA) or to receive capnothorax and CPAP (Group CC)
Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded at the following points:
- spontaneous breathing at FiO2=0.21; b) 10' after double lung ventilation (TLV); c) 10'after OLV; d) 10' after OLV and capnothorax (Group CA) or OLV, capnothorax and CPAP (Group CC) e) double lung ventilation (TLV) at the end of the surgical procedure Differences of DO2, shunt fraction (QS/QT), and derived variables between the two groups will be tested by T-test.
40 pts (20 per groups) will allow 80% power to deem as significant (alpha = 0.05) a difference of 50 mL/min in DO2 (with standard deviation of 50 mL/min) between the two managements of the non-ventilated lung.
If SaO2 will decrease below 90% an alveolar recruitment strategy will be performed and if not effective TLV will be initiated together with dropping the pt out of the study
- Being tested
- Capnothorax, Capnothorax and CPAP
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnothoraxProcedure or surgery
Insufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity.
Capnothorax and CPAPProcedure or surgery
Insufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity.
Continuous positive airway pressure of 10 cmH2O delivered by CF 800 Continuous flow CPAP, Drager.
| Study group | Role | What they receive |
|---|---|---|
| Capnothorax | Active comparator | Capnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg .Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded. Receives: Procedure: Capnothorax |
| Capnothorax and CPAP | Active comparator | Capnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg. CPAP on the non ventilated lung is set at 10 cm H2O and FiO2=1. Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded. Receives: Procedure: Capnothorax and CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen delivery
Oxygen delivery is cardiac output times arterial oxygen content
Measured: 10 min after institution of capnothotax or capnothorax and CPAP
Secondary outcomes (1)
Pulmonary shunt
Fraction of venous blood which is not oxygenated by the lungs
Measured: 10 min after institution of capnothotax or capnothorax and CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-Lung VentilationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luca salvi, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959515
- Sponsor's protocol ID
- CentroCM
- Acronym
- OLVinFACHIR
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Methods of Non-ventilated Lung Management on Oxygen Delivery (DO2) During One Lung Ventilation (OLV) in the Supine Position for Video Assisted Thoracoscopic (VATS) Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT02959515
- Acronym / sponsor ID
- OLVinFACHIR / CentroCM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- 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.
The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and OLV+capnothorax and CPAP.
Detailed description
One-lung ventilation (OLV) is utilized mainly during thoracic procedures when surgeon needs the lung deflated to expose the surgical field. In this situation both lungs are perfused but only one is ventilated resulting in high grade of shunt and eventually hypoxemia .
Most of thoracic procedures are performed with the pt lying on one side; the deflated lung receive less blood flow both for the gravity and for the hypoxic pulmonary vasoconstriction (HPV) thus reducing the shunt.
If the pt lyes supine, as in VATS atrial fibrillation (AF) surgical ablation, the protective effect of gravity is lost, shunt remains high and severe hypoxemia is common. Some algorithms are used to improve oxygenation during OLV: high fraction of inspired oxygen (FiO2), positive end expiratory pressure (PEEP) on the ventilated lung, continuous positive airway pressure (CPAP) on the deflated lung, but the latter can be used with caution during VATS because of the obstruction of the surgical field. Increasing the pressure in the pleural cavity with carbon dioxyde (CO2) (capnothorax) could decrease the blood flow in the deflated lung, helping in reducing shunt but this is not yet demonstrated and this manouver could decrease cardiac output. The oxygen delivery (DO2) is cardiac output (CO) by oxygen content and during this surgery both these factors could be compromised.
All consecutive pts electively subjected to OLV in supine position for VATS ablation of AF will be enrolled. On the day of surgery pts will be randomly allocated in two groups depending on the management of the non-ventilated lung (capnothorax or capnothorax and CPAP.
Pts in supine position; tracheal intubation with left-sided double lumen tube (DLT) and position confirmed by bronchoscopy. Lungs are initially ventilated with pressure controlled mode (PCV) at a tidal volume (TV) of 7 mL/kg, I:E ratio 1:2, respiratory rate (RR) to obtain a PaCO2 40-45 mmHg, FiO2 =1 and PEEP 5 cm H2O. During OLV inspiratory pressure is reduced to obtain a TV of 5 mL/Kg, maintaining FiO2=1, PEEP 5 cm H2O and adjusting RR to obtain a PaCO2 40-45 mmHg. Capnothorax is obtained by the insufflation of CO2 and maintained at a preset pressure of 10 mmHg. CPAP on the non ventilated lung is set at 10 cm H2O and FiO2=1.
After institution of OLV pts will be randomized to receive capnothorax alone (Group CA) or to receive capnothorax and CPAP (Group CC)
Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded at the following points:
- spontaneous breathing at FiO2=0.21; b) 10' after double lung ventilation (TLV); c) 10'after OLV; d) 10' after OLV and capnothorax (Group CA) or OLV, capnothorax and CPAP (Group CC) e) double lung ventilation (TLV) at the end of the surgical procedure Differences of DO2, shunt fraction (QS/QT), and derived variables between the two groups will be tested by T-test.
40 pts (20 per groups) will allow 80% power to deem as significant (alpha = 0.05) a difference of 50 mL/min in DO2 (with standard deviation of 50 mL/min) between the two managements of the non-ventilated lung.
If SaO2 will decrease below 90% an alveolar recruitment strategy will be performed and if not effective TLV will be initiated together with dropping the pt out of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capnothorax | Active comparator | Procedure: CapnothoraxCapnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg .Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded. |
| Capnothorax and CPAP | Active comparator | Procedure: Capnothorax and CPAPCapnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg. CPAP on the non ventilated lung is set at 10 cm H2O and FiO2=1. Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pts electively subjected to OLV in supine position for VATS ablation of AF and requiring OLV for > 30'
Key exclusion criteria (1 listed)
- Expected difficult positioning of DLT, severe obesity BMI > 35, uncompensated cardiac disease. OLV < 30'.
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 |
|---|---|---|
| CapnothoraxInsufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity. | Procedure or surgery | Capnothorax |
| Capnothorax and CPAPInsufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity. Continuous positive airway pressure of 10 cmH2O delivered by CF 800 Continuous flow CPAP, Drager. | Procedure or surgery | Capnothorax and CPAP |
Primary outcome
Oxygen delivery
Time frame: 10 min after institution of capnothotax or capnothorax and CPAP
Oxygen delivery is cardiac output times arterial oxygen content
1 secondary outcome
Pulmonary shunt
Time frame: 10 min after institution of capnothotax or capnothorax and CPAP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capnothorax and Capnothorax and CPAP in people with One-Lung Ventilation and Thoracic Surgery Video Assisted, run by Centro Cardiologico Monzino at 1 site in Italy.
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 1 inclusion and 1 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 luca salvi, MD (+39 02 58002 ext. 541, LUCA.SALVI@CCFM.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen delivery (time frame: 10 min after institution of capnothotax or capnothorax and CPAP). 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 9 Nov 2016.