HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04926649
• Other study ID #: 2021-59
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: June 2021
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 56
• Est. completion date: March 15, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Procedure:
• Differential 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.

Locations

Country	Name	City	State
China	Daping Hospital, Army Medical University	Chongqing	Chongqing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of arterial PaO2	Arterial PaO2 (in mmHg) defined as a measurement of partial pressure of oxygen in arterial blood	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]
Primary	Changes of PaO2/FiO2 ratio	PaO2/FiO2 ratio defined as the ratio of PaO2 to fractional inspired oxygen (FiO2 expressed as a fraction)	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	Changes of Heart rate	Heart rate in beat per minute	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	Changes of mean blood pressure	mean blood pressure in mmHg	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	Changes of cardiac stroke volume variation	Cardiac stroke volume variation in percentages	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	Changes of venous pressure of jugular vein	Venous pressure of jugular vein in cmH2O	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	Changes of tidal volume	Tidal volume of both lungs in milliliter	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	Changes of respiratory rates	Respiratory rates of both lungs in breath per minute	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	Changes of airway pressure	Airway pressure of both lungs in mmHg	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	Changes of end-tidal carbon dioxide tension	End-tidal carbon dioxide tension in mmHg	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	Changes of blood oxygen saturation	Blood oxygen saturation of both upper and lower extremities in percentages	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	Changes of the pulmonary shunt fraction	Qs/Qt = ((CcO2 - CaO2) / (CcO2 - CvO2)) * 100	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	Changes of regional cerebral oxygen saturation	regional cerebral oxygen saturation in percentages	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	Changes of the surgical field	The surgeon's evaluation of the surgical field, graded from 0 (no interference) to 3 (maximal interference)	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]