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Clinical Trials/NCT02959515
NCT02959515UnknownNot Applicable

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

Centro Cardiologico Monzino1 site in 1 country40 target enrollmentStarted: October 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Oxygen delivery

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Capnothorax (Procedure)

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.

Intervention: Capnothorax and CPAP (Procedure)

Outcomes

Primary Outcomes

Oxygen delivery

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

Oxygen delivery is cardiac output times arterial oxygen content

Secondary Outcomes

  • Pulmonary shunt(10 min after institution of capnothotax or capnothorax and CPAP)

Investigators

Sponsor
Centro Cardiologico Monzino
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

luca salvi

Anesthesia & ICU Senior consultant

Centro Cardiologico Monzino

Study Sites (1)

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