One-Lung Ventilation Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03508050 -
Clamping the Double Lumen Tube
|
N/A | |
| Completed |
NCT02919267 -
Physiology of Lung Collapse Under One-Lung Ventilation: Underlying Mechanisms
|
N/A | |
| Not yet recruiting |
NCT03649386 -
Heated Circuit for One-lung Ventilation
|
N/A | |
| Completed |
NCT02981537 -
Two-staged Approach in Positioning Endobronchial Blockers Without Fiberoptic Guidance
|
N/A | |
| Completed |
NCT03503565 -
Intraoperative Neuromuscular Blockade and Postoperative Atelectasis
|
||
| Completed |
NCT03296449 -
Comparison Between CPAP and HFJV During One-lung Ventilation in VATS
|
N/A | |
| Recruiting |
NCT04725318 -
Esophageal Pressure Measurements During One-lung Ventilation
|
||
| Completed |
NCT02137291 -
IPg2 Study: Left-sided Lung Isolation
|
N/A | |
| Completed |
NCT00486616 -
Examination of Double-Lumen Tube Placement by Functional Electrical Impedance Tomography
|
N/A | |
| Not yet recruiting |
NCT06376123 -
Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation
|
||
| Completed |
NCT04260451 -
Driving Pressure and Postoperative Pulmonary Complications in Thoracic Surgery
|
N/A | |
| Completed |
NCT05050552 -
Oxygen Reserve Index in One-Lung Ventilation During Elective Thoracic Operations
|
||
| Completed |
NCT04760262 -
The Effect of Anesthesia on Cerebral Oxygenation
|
||
| Recruiting |
NCT05907525 -
Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation
|
N/A | |
| Unknown status |
NCT01171560 -
Evaluation of the EZ Blocker
|
Phase 4 | |
| Completed |
NCT05946707 -
Effects of Oxygen Supply After Lung Isolation in Thoracic Surgery
|
N/A | |
| Completed |
NCT03234621 -
Protective Ventilation Strategy
|
N/A | |
| Completed |
NCT04740151 -
Individualized PEEP in Thoracic Surgery
|
N/A | |
| Not yet recruiting |
NCT06210256 -
Compared Unidirectional Valve Apparatus and Occluding the Non-ventilated Endobronchial Lumen for Lung Collapse.
|
N/A | |
| Active, not recruiting |
NCT02963025 -
Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery
|
N/A |