Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946707
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-05-25
Brief Title:
Effects of Oxygen Supply After Lung Isolation in Thoracic Surgery
Sponsor:
Medical University Innsbruck
Organization:
Medical University Innsbruck
Study Overview
Official Title:
Effects of Oxygen Supply on Hypoxic Pulmonary Vasoconstriction and Lung Collapse After Lung Isolation in Thoracic Surgery - a Prospective Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-05
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 goal of this randomized clinical trial is to compare a liberal versus restrictive oxygen supply fraction of inspired oxygen FiO2 strategy in patients scheduled for thoracic surgery requiring one-lung ventilation during lung isolation The primary and secondary outcome parameters are
oxygenation of the blood after 30 minutes of one-lung ventilation assessed by PaO2FiO2 ratio
time to lung collapse after start of one-lung ventilation
Participants in the control goup will receive an oxygen content of 100 before lung isolation which will be subsequently decreased to achieve normoxia or mild hyperoxia PaO2 of 75-120 mmHg
The intervention group will receive the previous during two-lung ventilation set oxygen content and after lung isolation oxygen supply will be increased to secure adequate oxygenation of the blood PaO2 75-120 mmHg during one-lung ventilation
The investigators hypothesize that a higher fraction of inspired oxygen may impede hypoxic pulmonary vasoconstriction of the collapsed lung and thus decrease overall oxygenation performance during one-lung ventilation Secondary endpoint will be the time to lung collapse as a lower fraction of inspired oxygen and thus a higher nitrogen content may impede lung collapse
oxygenation of the blood after 30 minutes of one-lung ventilation assessed by PaO2FiO2 ratio
time to lung collapse after start of one-lung ventilation
Participants in the control goup will receive an oxygen content of 100 before lung isolation which will be subsequently decreased to achieve normoxia or mild hyperoxia PaO2 of 75-120 mmHg
The intervention group will receive the previous during two-lung ventilation set oxygen content and after lung isolation oxygen supply will be increased to secure adequate oxygenation of the blood PaO2 75-120 mmHg during one-lung ventilation
The investigators hypothesize that a higher fraction of inspired oxygen may impede hypoxic pulmonary vasoconstriction of the collapsed lung and thus decrease overall oxygenation performance during one-lung ventilation Secondary endpoint will be the time to lung collapse as a lower fraction of inspired oxygen and thus a higher nitrogen content may impede lung collapse
Detailed Description:
After anesthesia induction and securing the airway with a double lumen tracheal tube the patient will be ventilated with pressure-controlled ventilation PCV and the following settings during two-lung ventilation TLV positive end-expiratory pressure of 5 cmH2O peak pressure set to achieve a tidal volume of 6-8 mlkg respiratory rate set to achieve normocapnia IE ratio set to 115 FiO2 adjusted to achieve normoxia After changing to lateral position the patient will be randomized to one of the following group
Decremental FiO2 titration FiO2 will be set to 10 five minutes before lung isolation and reduced consecutively during one-lung ventilation OLV according to paO2 measurement obtained from arterial blood gas samples to achieve normoxia paO2 of 75-120 mmHg
Incremental FiO2 titration FiO2 will be maintained to secure normoxia during the entire surgery This means that the previous FiO2 setting during two-lung ventilation will be continued and after OLV initiation the FiO2 has to be adjusted to secure normoxia assessed by continuous SpO2 measurement SpO2 of 92-96 and paO2 measurement obtained from arterial blood gas samples paO2 of 75-120 mmHg
During OLV the applied tidal volume will be reduced to 4-6 mlkg by an appropriate adjustment of peak pressure otherwise the ventilator settings will not be changed After 30 minutes of OLV the intervention period ends and because in both groups oxygenation will be adjusted to achieve a PaO2 of 75-120 mmHg during OLV the routine anesthetic regime of both groups will not differ in the further course of thoracic surgery
Decremental FiO2 titration FiO2 will be set to 10 five minutes before lung isolation and reduced consecutively during one-lung ventilation OLV according to paO2 measurement obtained from arterial blood gas samples to achieve normoxia paO2 of 75-120 mmHg
Incremental FiO2 titration FiO2 will be maintained to secure normoxia during the entire surgery This means that the previous FiO2 setting during two-lung ventilation will be continued and after OLV initiation the FiO2 has to be adjusted to secure normoxia assessed by continuous SpO2 measurement SpO2 of 92-96 and paO2 measurement obtained from arterial blood gas samples paO2 of 75-120 mmHg
During OLV the applied tidal volume will be reduced to 4-6 mlkg by an appropriate adjustment of peak pressure otherwise the ventilator settings will not be changed After 30 minutes of OLV the intervention period ends and because in both groups oxygenation will be adjusted to achieve a PaO2 of 75-120 mmHg during OLV the routine anesthetic regime of both groups will not differ in the further course of thoracic surgery
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