Back to resultsHFLVV for Hypoxemia in Robot-assisted Cardiac Surgery
Primary Purpose
Hypoxemia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Differential ventilation to the non-dependent lung
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxemia
Eligibility Criteria
Inclusion Criteria:
- scheduled for robot-assisted cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
- age <18 or > 70 years
- PaO2/FiO2 ratio < 300 mmHg before anesthesia induction
- American Society of Anesthesiologist (ASA) Grade > 3
- Patients who were converted to conventional open-chest procedure
Sites / Locations
- Daping Hospital, Army Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Experimental
Arm Label
Conventional ventilation group
CPAP group
HFLVV group
Arm Description
Conventional SLV and complementary with DLV when necessary. When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. The right lung was totally collapsed. If the SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted.
SLV of left lung and CPAP of right lung, and complementary with DLV when necessary. When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. After the right lung was totally collapsed, CPAP was started with the pressure less than 8 cmH2O. If SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted.
SLV of left lung and HFLVV of right lung, and complementary with DLV when necessary. When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. After the right lung was totally collapsed, HFLVV was started with tidal volume of 2ml/kg, respiratory rate of 60 bpm. If SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted.
Outcomes
Primary Outcome Measures
Changes of arterial PaO2
Arterial PaO2 (in mmHg) defined as a measurement of partial pressure of oxygen in arterial blood
Changes of PaO2/FiO2 ratio
PaO2/FiO2 ratio defined as the ratio of PaO2 to fractional inspired oxygen (FiO2 expressed as a fraction)
Secondary Outcome Measures
Changes of Heart rate
Heart rate in beat per minute
Changes of mean blood pressure
mean blood pressure in mmHg
Changes of cardiac stroke volume variation
Cardiac stroke volume variation in percentages
Changes of venous pressure of jugular vein
Venous pressure of jugular vein in cmH2O
Changes of tidal volume
Tidal volume of both lungs in milliliter
Changes of respiratory rates
Respiratory rates of both lungs in breath per minute
Changes of airway pressure
Airway pressure of both lungs in mmHg
Changes of end-tidal carbon dioxide tension
End-tidal carbon dioxide tension in mmHg
Changes of blood oxygen saturation
Blood oxygen saturation of both upper and lower extremities in percentages
Changes of the pulmonary shunt fraction
Qs/Qt = ((CcO2 - CaO2) / (CcO2 - CvO2)) * 100
Changes of regional cerebral oxygen saturation
regional cerebral oxygen saturation in percentages
Changes of the surgical field
The surgeon's evaluation of the surgical field, graded from 0 (no interference) to 3 (maximal interference)
Full Information
NCT ID
NCT04926649
First Posted
May 31, 2021
Last Updated
June 10, 2021
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04926649
Brief Title
HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery
Official Title
The High-frequency Low-volume Ventilation (HFLVV) for Hypoxemia During the Weaning From Cardiopulmonary Bypass in Robot-assisted Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
These robot-assisted cardiac surgeries usually require single-lung ventilation (SLV) to facilitate surgical exposure. SLV creates ventilation/perfusion mismatch and shunt (Qs:Qt) through the collapsed lung and leads to hypoxemia. Pulmonary gas exchange often deteriorates after cardiopulmonary bypass (CPB) because of ischemic tissue damage. In some cases, severe hypoxemia may require the cessation of surgical procedures and the initiation of double-lung ventilation to improve oxygenation. In this study, the investigator applied the continuous positive airway pressure (CPAP) or the high-frequency low-volume ventilation (HFLVV) to the non-dependent lung (differential ventilation) during the weaning from CPB. The investigator hypothesized that the differential ventilation would produce the least interference with the surgeon's exposure and better oxygenation. The investigators evaluate the airway pressure, shunt fraction, PaO2/FiO2, cerebral oximetry, surgical field condition and the length of stay in intensive care unit of patients underwent the robot-assisted cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional ventilation group
Arm Type
Sham Comparator
Arm Description
Conventional SLV and complementary with DLV when necessary. When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. The right lung was totally collapsed. If the SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted.
Arm Title
CPAP group
Arm Type
Active Comparator
Arm Description
SLV of left lung and CPAP of right lung, and complementary with DLV when necessary.
When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. After the right lung was totally collapsed, CPAP was started with the pressure less than 8 cmH2O. If SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted.
Arm Title
HFLVV group
Arm Type
Experimental
Arm Description
SLV of left lung and HFLVV of right lung, and complementary with DLV when necessary.
When SLV was initiated, the patient was ventilated with left lung. FiO2 of 1.0, tidal volume of 6ml/kg, respiratory rate of 16-24 bpm, PEEP of 5-10 cmH2O. After the right lung was totally collapsed, HFLVV was started with tidal volume of 2ml/kg, respiratory rate of 60 bpm. If SpO2 decreased lower than 90%, DLV was started and the operation was paused until the SpO2 increased to 100%. Then the operation was restarted.
Intervention Type
Procedure
Intervention Name(s)
Differential ventilation to the non-dependent lung
Intervention Description
When the hypoxemia occurs during sing lung ventilation in robot-assisted cardiac surgery, the non-dependent lung will be ventilated with normal tidal volume in conventional ways and the surgery procedure have to be ceased. In this trial, the non-dependent lung will be ventilated with the continuous positive airway pressure (CPAP) or the high-frequency low-volume ventilation (HFLVV) to prevent the hypoxemia.
Primary Outcome Measure Information:
Title
Changes of arterial PaO2
Description
Arterial PaO2 (in mmHg) defined as a measurement of partial pressure of oxygen in arterial blood
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of PaO2/FiO2 ratio
Description
PaO2/FiO2 ratio defined as the ratio of PaO2 to fractional inspired oxygen (FiO2 expressed as a fraction)
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Secondary Outcome Measure Information:
Title
Changes of Heart rate
Description
Heart rate in beat per minute
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV
Title
Changes of mean blood pressure
Description
mean blood pressure in mmHg
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of cardiac stroke volume variation
Description
Cardiac stroke volume variation in percentages
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of venous pressure of jugular vein
Description
Venous pressure of jugular vein in cmH2O
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of tidal volume
Description
Tidal volume of both lungs in milliliter
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of respiratory rates
Description
Respiratory rates of both lungs in breath per minute
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of airway pressure
Description
Airway pressure of both lungs in mmHg
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of end-tidal carbon dioxide tension
Description
End-tidal carbon dioxide tension in mmHg
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of blood oxygen saturation
Description
Blood oxygen saturation of both upper and lower extremities in percentages
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of the pulmonary shunt fraction
Description
Qs/Qt = ((CcO2 - CaO2) / (CcO2 - CvO2)) * 100
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of regional cerebral oxygen saturation
Description
regional cerebral oxygen saturation in percentages
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
Title
Changes of the surgical field
Description
The surgeon's evaluation of the surgical field, graded from 0 (no interference) to 3 (maximal interference)
Time Frame
5 min after induction of anesthesia during DLV, 5 min after SLV, 5 min after HFLVV, 5 min after CPB flow reduced to 1/3, 5min after CPB flow reduced to 2/3, 15min after resuming of DLV]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scheduled for robot-assisted cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
age <18 or > 70 years
PaO2/FiO2 ratio < 300 mmHg before anesthesia induction
American Society of Anesthesiologist (ASA) Grade > 3
Patients who were converted to conventional open-chest procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingxiang Mao, M.D., Ph.D.
Organizational Affiliation
Daping Hospital, Army Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping Hospital, Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31060627
Citation
Kremer R, Aboud W, Haberfeld O, Armali M, Barak M. Differential lung ventilation for increased oxygenation during one lung ventilation for video assisted lung surgery. J Cardiothorac Surg. 2019 May 6;14(1):89. doi: 10.1186/s13019-019-0910-2.
Results Reference
result
Learn more about this trial
HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery
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