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Comparison of Different Ventilation Mode During One-lung Ventilation

Primary Purpose

Thoracic Surgery, One Lung Ventilation, Ventilator-Induced Lung Injury

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
VCV mode
PCV mode
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thoracic Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted

Exclusion Criteria:

  • Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs

Sites / Locations

  • Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

volume controlled ventilation (VCV)

pressure controlled ventilation (PCV)

Arm Description

VCV mode, tide volume 6ml/kg, f 12-14, set fixed tide volume for each breath

PCV mode, pressure is adjusted to achieve tide volume 6ml/kg, f 12-14

Outcomes

Primary Outcome Measures

Airway pressure Ppeak
Airway pressure Ppeak in cmH2O.
Airway pressure Pplat
Airway pressure Pplat in cmH2O.
oxygenation index
Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is measured by gas monitor.
oxygenation index
Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is calculated by [21+4×oxygen flow(L/min)]×100%.

Secondary Outcome Measures

postoperative complications
including air leak, pneumonia, bronchopleural fistula, respiratory failure, ARDS, reintubation, tracheostomy, pulmonary embolism, arrhythmia requiring treatment, myocardial infarction, renal dysfunction, central neurologic event, sepsis, unexpected return to operating room, unexpected ICU admission and mortality within 30 days

Full Information

First Posted
February 6, 2017
Last Updated
February 21, 2017
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03061617
Brief Title
Comparison of Different Ventilation Mode During One-lung Ventilation
Official Title
Comparison of Pressure-controlled Ventilation With Volume-controlled Ventilation During One-lung Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is controversial as to which ventilation mode is better in one-lung ventilation(OLV), volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was designed to figure out if there was any difference between these two modes on oxygenation and postoperative complications under the condition of protective ventilation(PV).
Detailed Description
This is a single center, single blinded prospective study on two different ventilation mode during one lung ventilation for patients under video assistant thoracoscopy(VATS) lobectomy. After institutional approval and written informed consent were obtained, 60 patients with primary lung cancer under VATS lobectomy in Zhongshan Hospital Fudan University were enrolled and randomized into two groups:VCV group(group V) or PCV group(group P). Inclusion criteria were age between 18-75 years , ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted. Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, One Lung Ventilation, Ventilator-Induced Lung Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
volume controlled ventilation (VCV)
Arm Type
Other
Arm Description
VCV mode, tide volume 6ml/kg, f 12-14, set fixed tide volume for each breath
Arm Title
pressure controlled ventilation (PCV)
Arm Type
Experimental
Arm Description
PCV mode, pressure is adjusted to achieve tide volume 6ml/kg, f 12-14
Intervention Type
Other
Intervention Name(s)
VCV mode
Intervention Description
set fixed 6ml/kg tide volume
Intervention Type
Other
Intervention Name(s)
PCV mode
Intervention Description
adjust pressure to achieve tide volume of 6ml/kg
Primary Outcome Measure Information:
Title
Airway pressure Ppeak
Description
Airway pressure Ppeak in cmH2O.
Time Frame
during procedure
Title
Airway pressure Pplat
Description
Airway pressure Pplat in cmH2O.
Time Frame
during procedure
Title
oxygenation index
Description
Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is measured by gas monitor.
Time Frame
during procedure
Title
oxygenation index
Description
Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is calculated by [21+4×oxygen flow(L/min)]×100%.
Time Frame
surgery
Secondary Outcome Measure Information:
Title
postoperative complications
Description
including air leak, pneumonia, bronchopleural fistula, respiratory failure, ARDS, reintubation, tracheostomy, pulmonary embolism, arrhythmia requiring treatment, myocardial infarction, renal dysfunction, central neurologic event, sepsis, unexpected return to operating room, unexpected ICU admission and mortality within 30 days
Time Frame
within 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted Exclusion Criteria: Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25368784
Citation
Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. Epub 2014 Oct 27.
Results Reference
background
PubMed Identifier
26309682
Citation
Lin F, Pan L, Qian W, Ge W, Dai H, Liang Y. Comparison of three ventilatory modes during one-lung ventilation in elderly patients. Int J Clin Exp Med. 2015 Jun 15;8(6):9955-60. eCollection 2015.
Results Reference
background

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Comparison of Different Ventilation Mode During One-lung Ventilation

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