HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery

NCT ID: NCT04926649

Last Updated: 2021-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-03-15

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.

Conditions

Hypoxemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional ventilation group

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.

Group Type: SHAM_COMPARATOR

Differential ventilation to the non-dependent lung

Intervention Type: PROCEDURE

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.

CPAP group

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.

Group Type: ACTIVE_COMPARATOR

Differential ventilation to the non-dependent lung

Intervention Type: PROCEDURE

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.

HFLVV group

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.

Group Type: EXPERIMENTAL

Differential ventilation to the non-dependent lung

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Qingxiang Mao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingxiang Mao, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital, Army Medical University

Locations

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 31060627 (View on PubMed)

Other Identifiers

2021-59

Identifier Type: -

Identifier Source: org_study_id