Clinical trial NCT04175379: The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation
Official title: The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation : Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 279
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random sampling using random numbers is divided into three groups, and the ratio of each group is 1: 1: 1.
Primary purpose: TREATMENT

Brief summary: Permissive hypercapnia increased the survival rate in patients with acute respiratory distress syndrome (ARDS) who required mechanical ventilation in critical care medicine. This has been explained by its association with ventilator induced lung injury. Since then, a protective lung ventilation strategy has been very important, with a low tidal volume of 4-6 ml/kg. Patients undergoing surgery will inevitably require mechanical ventilation. In particular, patients undergoing one lung ventilation for thoracic surgery may have increased airway pressure and a greater chance of ventilator induced lung injury. Recently, protective lung ventilation has been applied to patients undergoing one ung ventilation during thoracic surgery. The purpose of this study is to evaluate the difference in the degree of pulmonary oxygenation and the incidence of postoperative pulmonary complications in hypercapnia induced by controlling the respiratory rate with a constant tidal volume.


Eligibility criteria: Inclusion Criteria:

1. Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy or segmentectomy with one lung ventilation during surgery.
2. American Society of Anesthesiologists (ASA) classification 1\~3

Exclusion Criteria:

1. patients with heart failure (NYHA class III\~IV)
2. patients who are having moderate obstructive lung disease or restrictive lung disease
3. Low DLCO (\< 75%)
4. patients with brain disease history or increased ICP
5. patients with pulmonary hypertension (mean PAP\>25mmHg)
6. patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL)
7. patients with pre-existing hypercapnia or metabolic acidosis
8. body mass index (BMI) \> 30 kg/m2
9. patients who have had contralateral lung surgery
10. patients who cannot read explanation and consent form
11. patients who are pregnant

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: about 60 minutes after reaching to the target PaCO2 (T2)
Secondary outcomes:
measure: Post-op complication: desaturation event
timeFrame: first 3 days after surgery
measure: Post-op complication: oxygen therapy
timeFrame: first 2~7 days after surgery
measure: Post-op complication
timeFrame: 30 days after surgery
measure: Post-op complication: hospitalized days
timeFrame: 30 days after surgery
measure: Post-op complication: ICU days
timeFrame: 30 days after surgery
measure: Dead
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References: