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The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation

Not Applicable
Conditions
Thoracic Surgery
Interventions
Other: group 50
Other: group 60
Other: group 40
Registration Number
NCT04175379
Lead Sponsor
Yonsei University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
279
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group 50group 50In group 50, target PaCO2 is 50 during surgery
group 60group 60In group 60, target PaCO2 is 60 during surgery
group 40group 40In group 40, target PaCO2 is 40 during surgery
Primary Outcome Measures
NameTimeMethod
PaO2/FiO2 ratioabout 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 Outcome Measures
NameTimeMethod
Post-op complication: desaturation eventfirst 3 days after surgery

desaturation event (\<90%) the first 3 days after surgery

Post-op complication: hospitalized days30 days after surgery

length of hospitalized stays CU days, expire

Post-op complication: oxygen therapyfirst 2~7 days after surgery

necessity of oxygen therapy within the first 2\~7 days after surgery hospitalized days, ICU days, expire

Post-op complication30 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: ICU days30 days after surgery

length of ICU stays

Dead30 days after surgery

patient has been dead or not

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

🇰🇷

Seoul, Korea, Republic of

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