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

NCT ID: NCT04175379

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2021-10-31

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.

Conditions

Thoracic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group 40

In group 40, target PaCO2 is 40 during surgery

Group Type: EXPERIMENTAL

group 40

Intervention Type: OTHER

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

In group 50, target PaCO2 is 50 during surgery

Group Type: EXPERIMENTAL

group 50

Intervention Type: OTHER

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

In group 60, target PaCO2 is 60 during surgery

Group Type: EXPERIMENTAL

group 60

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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).

Intervention Type: OTHER

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

References

Joe YE, Lee CY, Kim N, Lee K, Kang SJ, Oh YJ. Effect of permissive hypercarbia on lung oxygenation during one-lung ventilation and postoperative pulmonary complications in patients undergoing thoracic surgery: A prospective randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):691-698. doi: 10.1097/EJA.0000000000001873. Epub 2023 Jul 15.

Reference Type: DERIVED

PMID: 37455644 (View on PubMed)

Other Identifiers

4-2019-0904

Identifier Type: -

Identifier Source: org_study_id