## Protocol Section
### Identification Module
**NCT ID:** NCT04175379

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

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

#### Organization Study ID Info
**ID:** 4-2019-0904
#### Organization
**Class:** OTHER
**Full Name:** Yonsei University
### Status Module
#### Completion Date
**Date:** 2021-10

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2020-01-02

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-11-25

**Type:** ACTUAL

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2019-11-25
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-15
**Study First Submit QC Date:** 2019-11-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yonsei University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Thoracic Surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** TRIPLE

**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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 279

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In group 40, target PaCO2 is 40 during surgery

**Intervention Names:**

- Other: group 40

**Label:** group 40

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In group 50, target PaCO2 is 50 during surgery

**Intervention Names:**

- Other: group 50

**Label:** group 50

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** In group 60, target PaCO2 is 60 during surgery

**Intervention Names:**

- Other: group 60

**Label:** group 60

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group 40

**Description:** 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).

**Name:** group 40

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- group 50

**Description:** 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).

**Name:** group 50

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- group 60

**Description:** 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).

**Name:** group 60

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** (arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2

**Measure:** PaO2/FiO2 ratio

**Time Frame:** about 60 minutes after reaching to the target PaCO2 (T2)

#### Secondary Outcomes

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

**Measure:** Post-op complication: desaturation event

**Time Frame:** first 3 days after surgery

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

**Measure:** Post-op complication: oxygen therapy

**Time Frame:** first 2~7 days after surgery

**Description:** 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.

**Measure:** Post-op complication

**Time Frame:** 30 days after surgery

**Description:** length of hospitalized stays CU days, expire

**Measure:** Post-op complication: hospitalized days

**Time Frame:** 30 days after surgery

**Description:** length of ICU stays

**Measure:** Post-op complication: ICU days

**Time Frame:** 30 days after surgery

**Description:** patient has been dead or not

**Measure:** Dead

**Time Frame:** 30 days after surgery

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

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

**Zip:** 03722

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9986

- Name: Hypercapnia

- Relevance: HIGH

- As Found: Hypercapnia

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006935

- Term: Hypercapnia

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
