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

Primary Purpose

Thoracic Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
group 40
group 50
group 60
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Surgery

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

group 40

group 50

group 60

Arm Description

In group 40, target PaCO2 is 40 during surgery

In group 50, target PaCO2 is 50 during surgery

In group 60, target PaCO2 is 60 during surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Post-op complication: desaturation event
desaturation event (<90%) the first 3 days after surgery
Post-op complication: oxygen therapy
necessity of oxygen therapy within the first 2~7 days after surgery hospitalized days, ICU days, expire
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.
Post-op complication: hospitalized days
length of hospitalized stays CU days, expire
Post-op complication: ICU days
length of ICU stays
Dead
patient has been dead or not

Full Information

First Posted
November 15, 2019
Last Updated
December 30, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random sampling using random numbers is divided into three groups, and the ratio of each group is 1: 1: 1.
Masking
ParticipantCare ProviderOutcomes Assessor
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.
Allocation
Randomized
Enrollment
279 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 40
Arm Type
Experimental
Arm Description
In group 40, target PaCO2 is 40 during surgery
Arm Title
group 50
Arm Type
Experimental
Arm Description
In group 50, target PaCO2 is 50 during surgery
Arm Title
group 60
Arm Type
Experimental
Arm Description
In group 60, target PaCO2 is 60 during surgery
Intervention Type
Other
Intervention Name(s)
group 40
Intervention 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).
Intervention Type
Other
Intervention Name(s)
group 50
Intervention 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).
Intervention Type
Other
Intervention Name(s)
group 60
Intervention 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).
Primary Outcome Measure Information:
Title
PaO2/FiO2 ratio
Description
(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2
Time Frame
about 60 minutes after reaching to the target PaCO2 (T2)
Secondary Outcome Measure Information:
Title
Post-op complication: desaturation event
Description
desaturation event (<90%) the first 3 days after surgery
Time Frame
first 3 days after surgery
Title
Post-op complication: oxygen therapy
Description
necessity of oxygen therapy within the first 2~7 days after surgery hospitalized days, ICU days, expire
Time Frame
first 2~7 days after surgery
Title
Post-op complication
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.
Time Frame
30 days after surgery
Title
Post-op complication: hospitalized days
Description
length of hospitalized stays CU days, expire
Time Frame
30 days after surgery
Title
Post-op complication: ICU days
Description
length of ICU stays
Time Frame
30 days after surgery
Title
Dead
Description
patient has been dead or not
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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