Effect of Apneic Oxygenation of the Non-ventilated Lung During Lung Cancer Surgery.
ConditionLung Cancer (Diagnosis)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOsijek University Hospital
About this trial
This study investigates the effect of apneic oxygenation of the non-ventilated lung on local and systemic inflammatory response during lung cancer surgery.
Patients undergoing surgical resection of lung cancer often require one-lung ventilation during anaesthesia. This results in alveolar hypoxia accompanied by upregulated expression of inflammatory markers. Apneic oxygenation of the non-ventiladed lung may influence inflammatory processes and oxygenation during surgery. The aim of this study is to evaluate whether apneic oxygenation affects inflammatory markers in lung tissue and postoperative recovery in patients undergoing lung cancer surgery. The study is conducted at a single center and includes adult patients scheduled for elective lung cancer surgery. Data will be collected durig the perioperative period. The results of this study may contribute to improved anaesthetic management and patient outcomes during thoracic surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Patients scheduled to undergo surgical resection of a single lung segment for lung cancer
Written informed consent provided
Disqualifiers
Age younger than 18 years
Chronic corticosteroid therapy and/or other immunomodulatory treatments
Surgical procedure expected to last less than 2 hours
Intraoperative hemodynamic instability, defined as: Mean arterial pressure < 60 mmHg for more than 30 minutes despite adequate volume resuscitation, requirement for high-dose vasopressor support (norepinephrine > 0.2 µg/kg/min)
Trial design
Design model
Parallel
Treatments tested in this trial
Apnoeic Oxygenation
Procedure/SurgeryApneic oxygenation of the non-ventilated lung is applied during lung cancer surgery to maintain oxygenation and decrease inflammatory response while the lung is not mechanically ventilated.
Standard Ventilation
Procedure/SurgeryStandard ventilation is applied during lung cancer surgery according to routine clinical practice.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Apneic OxygenationExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Expression of HIF -1α in lung tissue
Expression of hypoxia inducible factor 1 alpha (HIF 1α ) in lung tissue will be assessed to evaluate tissue hypoxia in patients receiving apneic oxygenation of the non-ventilated lung compared with those receiving standard ventilation during lung cancer surgery.
Time frame
Intraoperative (during lung cancer surgery)2
Expression of IL-6 in lung tissue
Expression of interleukin 6 (IL-6) in lung tissue will be assessed to evaluate the local inflammatory response in patients receiving apneic oxygenation of the non-ventilated lung compared with those receiving standard ventilation during lung cancer surgery.
Time frame
Intraoperative (during lung cancer surgery)Secondary outcomes
1
Changes in leukocyte count
Changes in peripheral blood leukocyte count from preoperative baseline will be measured to assess systemic inflammatory response associated with apneic oxygenation compared with standard ventilation.
Time frame
From preoperative baseline to 24 hours after surgery.2
Changes in neutrophile count
Changes in peripheral blood neutrophil count from preoperative baseline will be measured to asses systemic inflammatory response associated with apneic oxygenation compared with standard ventilation.
Time frame
From preoperative baseline to 24 hours after surgery.3
Changes in arterial oxygen partial pressure (PaO2)
Changes in arterial oxygen partial pressure (PaO2) from preoperative baseline will be measured to assess respiratory effects associated with apneic oxygenation compared with standard ventilation.
Time frame
From preoperative baseline to 24 hours after surgery.4
Changes in arterial carbon dioxide partial pressure (PaCO2)
Changes in arterial carbon dioxide partial pressure (PaCO2) will be measured to assess respiratory effects associated with apneic oxygenation compared with standard ventilation.
Time frame
From preoperative baseline to 24 hours after surgery.Sponsors and contacts
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Source ClinicalTrials.gov