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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Centro Cardiologico Monzino

    Milan, 20138

    Luca salvi, MD, +39 02 58002 ext. 541, luca.salvi@ccfm.it

    Recruiting

Other trials in Italy

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:

  1. 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 groups in NCT02959515
Study groupRoleWhat they receive
CapnothoraxActive comparatorCapnothorax 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 CPAPActive comparatorCapnothorax 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.

  1. 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)
  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.

  1. First posted9 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionMar 2018 (estimated)
  4. Study completionApr 2018 (estimated)

Resources

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)
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

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.

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