ClinicalTrials.gg
Status unknownNCT02959515OLVinFACHIRUpdated Nov 9, 2016

The Effects of Different Types of Non-ventilated Lung Management on DO2 During OLV in the Supine Position

An interventional study of Capnothorax and Capnothorax and CPAP in One-Lung Ventilation, Thoracic Surgery Video Assisted and Supine Position, sponsored by Centro Cardiologico Monzino. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-11-09.

Sponsored by Centro Cardiologico Monzino · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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:

a) 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

02

Conditions studied

  • One-Lung Ventilation
  • Thoracic Surgery Video Assisted
  • Supine Position
03

In context

Lead sponsor

Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pts electively subjected to OLV in supine position for VATS ablation of AF and requiring OLV for > 30'

Exclusion criteria

Exclusion Criteria:

  • Expected difficult positioning of DLT, severe obesity BMI > 35, uncompensated cardiac disease. OLV \< 30'.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Capnothorax

    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.

    Procedure: Capnothorax

  • Active comparator
    Capnothorax and CPAP

    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.

    Procedure: Capnothorax and CPAP

Interventions

  • ProcedureCapnothorax

    Insufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity.

  • ProcedureCapnothorax and CPAP

    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.

06

What researchers measure

Primary outcomes

  1. Oxygen delivery

    Oxygen delivery is cardiac output times arterial oxygen content

    Time frame: 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

    Time frame: 10 min after institution of capnothotax or capnothorax and CPAP

07

Study locations

1 of 1 sites recruiting
  • Centro Cardiologico Monzino
    Milan, 20138, Italy
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2016, a primary completion of Mar 2018 and a completion of Apr 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2016
First posted
Nov 9, 2016
Start
Oct 2016
Primary completionEst.
Mar 2018
CompletionEst.
Apr 2018
Last update
Nov 9, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02959515
Lead sponsor
Centro Cardiologico Monzino
Responsible party
luca salvi (Anesthesia & ICU Senior consultant, Centro Cardiologico Monzino) — Principal investigator
First posted
Nov 9, 2016
Start date
Oct 2016
Primary completion
Mar 2018 (estimated)
Completion
Apr 2018 (estimated)
Last update
Nov 9, 2016

Study contacts

luca salvi, MD
Contact
LUCA.SALVI@CCFM.IT
+39 02 58002 ext. 541

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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