Thoracic Surgery
Conditions
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.
Interventions
OTHERgroup 40
During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 40 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
OTHERgroup 50
During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 50 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
OTHERgroup 60
During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 60 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients, care givers and outcomes assessors are blinded. The investigator should not be included in the blind because they need to adjust the ventilator settings.
Intervention model description
Random sampling using random numbers is divided into three groups, and the ratio of each group is 1: 1: 1.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaO2/FiO2 ratio | about 60 minutes after reaching to the target PaCO2 (T2) | (arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dead | 30 days after surgery | patient has been dead or not |
| Post-op complication: desaturation event | first 3 days after surgery | desaturation event (\<90%) the first 3 days after surgery |
| Post-op complication: ICU days | 30 days after surgery | length of ICU stays |
| Post-op complication | 30 days after surgery | The presence or absence of post operative complication like pneumonia, acute lung injury, re-intubation, ICU admission, ventilator care, empyema, broncho-pleura fistula, air-leakage, pleural effusion, pulmonary embolism, tracheostomy, wound infection, AKI, MI, etc. |
| Post-op complication: hospitalized days | 30 days after surgery | length of hospitalized stays CU days, expire |
| Post-op complication: oxygen therapy | first 2~7 days after surgery | necessity of oxygen therapy within the first 2\ 7 days after surgery hospitalized days, ICU days, expire |
Countries
South Korea
Outcome results
None listed