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

Thoracic Surgery Clinical Trial

Official title:

The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation : Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04175379
• Other study ID #: 4-2019-0904
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: October 2021

Study information

• Verified date: December 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 279
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Thoracic Surgery

Intervention

Other:
• group 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).
• group 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).
• group 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).

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio	(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2	about 60 minutes after reaching to the target PaCO2 (T2)
Secondary	Post-op complication: desaturation event	desaturation event (<90%) the first 3 days after surgery	first 3 days after surgery
Secondary	Post-op complication: oxygen therapy	necessity of oxygen therapy within the first 2~7 days after surgery hospitalized days, ICU days, expire	first 2~7 days after surgery
Secondary	Post-op complication	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.	30 days after surgery
Secondary	Post-op complication: hospitalized days	length of hospitalized stays CU days, expire	30 days after surgery
Secondary	Post-op complication: ICU days	length of ICU stays	30 days after surgery
Secondary	Dead	patient has been dead or not	30 days after surgery