HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery

NCT04926649 | Unknown

• 1 other identifier: 2021-59
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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]

• 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 Outcomes (12)

• Changes of Heart rate

  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

• Changes of mean blood pressure

  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]

• Changes of cardiac stroke volume variation

  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]

• Changes of venous pressure of jugular vein

  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]

• Changes of tidal volume

  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]

Study Arms (3)

Conventional ventilation group

SHAM COMPARATOR

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.

Procedure: Differential ventilation to the non-dependent lung

CPAP group

ACTIVE COMPARATOR

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.

Procedure: Differential ventilation to the non-dependent lung

HFLVV group

EXPERIMENTAL

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.

Procedure: Differential ventilation to the non-dependent lung

Interventions

Differential ventilation to the non-dependent lung 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; Conventional ventilation group; HFLVV group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for robot-assisted cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Daping Hospital, Army Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related 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.

  PMID: 31060627 RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qingxiang Mao, M.D., Ph.D.

  Daping Hospital, Army Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 15, 2021
• Study Start: June 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: March 15, 2022
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)