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

NCT04175379 | Unknown

• 1 other identifier: 4-2019-0904
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Post-op complication: desaturation event

  first 3 days after surgery

• Post-op complication: oxygen therapy

  first 2~7 days after surgery

• Post-op complication

  30 days after surgery

• Post-op complication: hospitalized days

  30 days after surgery

• Post-op complication: ICU days

  30 days after surgery

Study Arms (3)

group 40

EXPERIMENTAL

In group 40, target PaCO2 is 40 during surgery

Other: group 40

group 50

EXPERIMENTAL

In group 50, target PaCO2 is 50 during surgery

Other: group 50

group 60

EXPERIMENTAL

In group 60, target PaCO2 is 60 during surgery

Other: group 60

Interventions

group 40 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 40

group 50 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 50

group 60 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).

group 60

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 37455644 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random sampling using random numbers is divided into three groups, and the ratio of each group is 1: 1: 1.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 25, 2019
• Study Start: November 25, 2019
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)