Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376123
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-17
Brief Title:
Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation
Sponsor:
Bezmialem Vakif University
Organization:
Bezmialem Vakif University
Study Overview
Official Title:
Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen The importance of our study is to collect some of the patients parameters on a nomogram in the preoperative period to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly
Detailed Description:
The shunt that occurs during one lung ventilation varies for each patient and depends on many parameters In this study our aim was to predict the level of shunting during anaesthesia using readily available preoperative data It is important to predict the hypoxia that will develop due to the shunt and to plan the methods that can be applied to reduce the shunt in terms of patient safety One of the most reliable data reflecting the shunt level is the gradient of alvelo- arterial oxygen concentration The calculation of alveolo-arterial oxygen gradient A-a O2 gradient is based on easily accessible parameters pO2 pCO2 FiO2 age The secondary aim of the study is to follow how the A-a O2 gradient oxygen difference between alveolar and arterial blood changes over time during surgery
Demographic data planned operation comorbidities side of surgery ASA score preoperative haemoglobin level FEV1 forced expiratory volume in 1 minute FEV1FVC forced expiratory volume in 1 minuteforced vital capacity ratio and EF ejection fraction will be recorded before surgeryFEV1 FEV1FVC ratio values will be measured by spirometry test Spirometry is a preoperative test routinely performed in all patients undergoing one lung ventilation EF will be measured by preoperative echocadiography which is also performed during the preoperative preparation of all patients scheduled for lung surgery Patients undergoing VATS video-assisted thoracotomy surgery with planned lung resection lobectomy pulmonectomy segmentectomy will be included in the study and all will be operated in the lateral decubitus position
Once the patient is on the operating table routine haemodynamic monitoring heart rate non-invasive blood pressure and blood oxygen saturation will be performed
The patient will then have an arterial cannula inserted for invasive arterial monitoring It is a routine practice in major surgeries for blood gas monitoring haemorrhage monitoring and monitoring of sudden blood pressure fluctuations After insertion of the arterial cannula blood gas will be taken in room air and arterial pO2 partial oxygen pressure arterial pCO2 partial carbon dioxide pressure and arterial SpO2 oxygen saturation will be recorded At the same time a venous blood sample from any vein in the upper limb will be taken in room air and vSpO2 venous blood oxygen saturation will be recorded
All patients will undergo general anaesthesia and orotracheal intubation with a double lumen tube
For anaesthesia induction 1 mcgkg fentanyl 2 mgkg propofol and 06 mgkg rocuronium will be administered After adequate mask ventilation and complete muscle relaxation a double lumen intubation tube will be placed into the trachea by direct laryngoscopy After the position of the tube and whether it is in the correct bronchus is supported by bronchoscopy the patient will be connected to the mechanical ventilator and lateral decubitus provided that the side to be operated on remains on top will be given Ventilator parameters will be selected the same for all patients During two-lung ventilation tidal volume 8 mlkg respiratory rate 12 peep 5 and FiO2 fraction of inspired oxygen 60 During one-lung ventilation tidal volume will be set to 6 mlmin respiratory rate 15 peep 5 and FiO2 70 All patients will be ventilated in volume control mode
At this stage EtCO2 end-tidal carbon dioxide will be measured separately in both lungs For this first the airway from the lower lung will be clamped and the EtCO2 value will be recorded dEtCO2 - dependent lung EtCO2 Then vice versa the airway from the lower lung will be clamped and the EtCO2 value obtained ndEtCO2 - non-dependent lung EtCO2 will be recorded The difference between these two values D-EtCO2 delta - end-tidal carbon dioxide will be added to the data
After these steps one-lung ventilation will be started and the first A-a oxygen gradient will be recorded
Demographic data planned operation comorbidities side of surgery ASA score preoperative haemoglobin level FEV1 forced expiratory volume in 1 minute FEV1FVC forced expiratory volume in 1 minuteforced vital capacity ratio and EF ejection fraction will be recorded before surgeryFEV1 FEV1FVC ratio values will be measured by spirometry test Spirometry is a preoperative test routinely performed in all patients undergoing one lung ventilation EF will be measured by preoperative echocadiography which is also performed during the preoperative preparation of all patients scheduled for lung surgery Patients undergoing VATS video-assisted thoracotomy surgery with planned lung resection lobectomy pulmonectomy segmentectomy will be included in the study and all will be operated in the lateral decubitus position
Once the patient is on the operating table routine haemodynamic monitoring heart rate non-invasive blood pressure and blood oxygen saturation will be performed
The patient will then have an arterial cannula inserted for invasive arterial monitoring It is a routine practice in major surgeries for blood gas monitoring haemorrhage monitoring and monitoring of sudden blood pressure fluctuations After insertion of the arterial cannula blood gas will be taken in room air and arterial pO2 partial oxygen pressure arterial pCO2 partial carbon dioxide pressure and arterial SpO2 oxygen saturation will be recorded At the same time a venous blood sample from any vein in the upper limb will be taken in room air and vSpO2 venous blood oxygen saturation will be recorded
All patients will undergo general anaesthesia and orotracheal intubation with a double lumen tube
For anaesthesia induction 1 mcgkg fentanyl 2 mgkg propofol and 06 mgkg rocuronium will be administered After adequate mask ventilation and complete muscle relaxation a double lumen intubation tube will be placed into the trachea by direct laryngoscopy After the position of the tube and whether it is in the correct bronchus is supported by bronchoscopy the patient will be connected to the mechanical ventilator and lateral decubitus provided that the side to be operated on remains on top will be given Ventilator parameters will be selected the same for all patients During two-lung ventilation tidal volume 8 mlkg respiratory rate 12 peep 5 and FiO2 fraction of inspired oxygen 60 During one-lung ventilation tidal volume will be set to 6 mlmin respiratory rate 15 peep 5 and FiO2 70 All patients will be ventilated in volume control mode
At this stage EtCO2 end-tidal carbon dioxide will be measured separately in both lungs For this first the airway from the lower lung will be clamped and the EtCO2 value will be recorded dEtCO2 - dependent lung EtCO2 Then vice versa the airway from the lower lung will be clamped and the EtCO2 value obtained ndEtCO2 - non-dependent lung EtCO2 will be recorded The difference between these two values D-EtCO2 delta - end-tidal carbon dioxide will be added to the data
After these steps one-lung ventilation will be started and the first A-a oxygen gradient will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None