Clinical Trials Logo

Clinical Trial Summary

One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has been discussed in multiple studies. Literature shows different ventilation strategies and possible hypoxemia has been attributed to several issues.

Port-access cardiac surgical procedures ("key hole surgery" including mitral valve repair or prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a combination of these) require the use of OLV as well. Its effect on oxygen saturation has not been studied previously.

The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV during port-access in comparison to oxygen saturation throughout OLV during lateral decubitus thoracotomies.


Clinical Trial Description

OLV is a technique that allows isolation of the individual lung under anesthesia. It is required for a number of thoracic surgical procedures as well as port-access procedures.

The use of a double lumen tube allows easy switching from two-lung to single lung ventilation.

For many thoracic operations the patient will be in the lateral decubitus position. The primary physiologic change that takes place on initiation of OLV is the presence of trans-pulmonary shunting, causing impaired oxygenation and occasionally hypoxemia. The degree of shunt is reduced due to the effect of gravity which increases pulmonary blood flow to the dependent lung and it will be further decreased due to a phenomenon termed hypoxic pulmonary vasoconstriction (HPV).

Hypoxemia may occur during OLV in lateral decubitus position due to the restriction of the dependent lung expansion caused by mediastinal weight therefore leading to atelectasis. Increased ventilation pressure and lung volume of the dependent lung impedes perfusion and contributes to hypoxemia.

Presentation of hypoxemia during OLV is multifactorial. It depends on the operation side (OLV better in left thoracotomies), on preoperative lung function [best indicator = Partial Pressure of Oxygen in Arterial Blood (PaO2) divided by Fraction of Inspired Oxygen (FIO2)] and on the distribution of perfusion. The PaO2/FIO2 is the best parameter to describe the full spectrum of ventilation-perfusion abnormalities, independent of the inspired oxygen concentration level.

The patients are divided into 2 groups according to the surgical procedure as follows:

Port-access group (n=25), and lateral decubitus lung surgery group (n=25). Standard monitoring will be applied intraoperatively [electrocardiography (ECG), pulse-oxymetry (SpO2), invasive and non-invasive blood pressure]. After induction of anesthesia, an appropriately sized double lumen tube will be inserted and its position will be checked using fibroscopy. All patients will be placed on a volume controlled mode of ventilation with the following settings: tidal volume between 5 and 10 ml/kg and FIO2 at 50% and 4 cm H2O of positive end-expiratory pressure (PEEP). Respiratory frequency and tidal volume will be adjusted to maintain end-tidal carbon dioxide (ETCO2) between 30 and 40 mmHg. ETCO2 levels and SpO2 will be monitored continuously.

If SpO2 declines below 90% the ventilator settings will be adapted according to the following protocol: First the FIO2 is increased to 80%. If this is insufficient FIO2 is increased to 100%. If this remains insufficient, continuous positive airway pressure (CPAP) [5 cm water (H2O) pressure] is applied to the non-ventilated lung. If this is still insufficient the surgeon will be asked to allow for temporary recruitment of the non-ventilated lung. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01744886
Study type Interventional
Source Onze Lieve Vrouw Hospital
Contact
Status Terminated
Phase N/A
Start date December 2012
Completion date September 2013

See also
  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
Recruiting NCT02959515 - The Effects of Different Types of Non-ventilated Lung Management on DO2 During OLV in the Supine Position 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
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
Recruiting 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