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HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery

The High-frequency Low-volume Ventilation (HFLVV) for Hypoxemia During the Weaning From Cardiopulmonary Bypass in Robot-assisted Cardiac Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04926649
Enrollment
56
Registered
2021-06-15
Start date
2021-06-01
Completion date
2022-03-15
Last updated
2021-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia

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.

Interventions

PROCEDUREDifferential ventilation to the non-dependent lung

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.

Sponsors

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of arterial PaO25 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]Arterial PaO2 (in mmHg) defined as a measurement of partial pressure of oxygen in arterial blood
Changes of PaO2/FiO2 ratio5 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]PaO2/FiO2 ratio defined as the ratio of PaO2 to fractional inspired oxygen (FiO2 expressed as a fraction)

Secondary

MeasureTime frameDescription
Changes of cardiac stroke volume variation5 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]Cardiac stroke volume variation in percentages
Changes of venous pressure of jugular vein5 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]Venous pressure of jugular vein in cmH2O
Changes of tidal volume5 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]Tidal volume of both lungs in milliliter
Changes of respiratory rates5 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]Respiratory rates of both lungs in breath per minute
Changes of airway pressure5 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]Airway pressure of both lungs in mmHg
Changes of Heart rate5 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 DLVHeart rate in beat per minute
Changes of blood oxygen saturation5 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]Blood oxygen saturation of both upper and lower extremities in percentages
Changes of the pulmonary shunt fraction5 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]Qs/Qt = ((CcO2 - CaO2) / (CcO2 - CvO2)) \* 100
Changes of regional cerebral oxygen saturation5 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]regional cerebral oxygen saturation in percentages
Changes of the surgical field5 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]The surgeon's evaluation of the surgical field, graded from 0 (no interference) to 3 (maximal interference)
Changes of end-tidal carbon dioxide tension5 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]End-tidal carbon dioxide tension in mmHg
Changes of mean blood pressure5 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]mean blood pressure in mmHg

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026