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NCT Number: NCT06056401

Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position

Carbon dioxide (CO2) pneumoperitoneum and clasp-knife positioning are commonly used to improve surgical access during robot-assisted laparoscopic urological surgery. However, these methods are sometimes associated with several unwanted cardiopulmonary effects such as increased mean arterial pressure, decreased pulmonary compliance and functional residual capacity, increased peak inspiratory pressure, and respiratory acidosis in association with hypercarbia. Volume-controlled ventilation (VCV) is the most commonly used method of ventilation during general anesthesia. It provides fixed minute ventilation and pulmonary resistance, which affect airway pressure. In pressure-controlled ventilation (PCV), constant inspiratory airway pressure can be achieved by decelerating the flow. However, minute ventilation is not fixed . CO2 pneumoperitoneum in the clasp-knife positioning can influence hemodynamic variables, including blood pressure, heart rate, and cardiac output. This is because changes in airway pressure affect intrathoracic pressure and the function of the heart itself. In this randomized study, we investigated the effects of VCV and PCV on peak inspiratory pressure during robot-assisted laparoscopic urological surgery involving CO2 pneumoperitoneum in the clasp-knife position.

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Key information

Conditions

Mechanical Ventilation General Anesthesia Robotic Surgery Urological Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cai Xinyuan

Guangzhou, Guangdong, 510060, China

About this study

After careful screening, 60 patients were enrolled in the trial. The investigators monitored patients' breathing, circulation and carbon metabolism by measuring arterial gas, cardiac output monitoring, respiratory parameters and circulation parameters at different times in both groups of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing urological surgery in clasp-knife position
  • between the age of 18 and 65
  • America Society of Anesthesiologist Grades I-II.

Exclusion criteria

  • Morbid obesity
  • systolic blood pressure < 90 mmHg)
  • heart rate < 60 beats per minute or > 100 beats per minute
  • peripheral blood oxygen saturation < 90%
  • Complicated with severe liver and kidney injury.

Treatment and study plan

record Hemodynamic variables, respiratory variables and arterial blood gas at specific times

Behavioral

Hemodynamic variables, respiratory variables and arterial blood gas were measured and recorded 15 minutes after induction of anesthesia (T1), 15 minutes after establishment of a folding knife position (T2), 30 and 60 minutes after CO2 pneumoconiosis (T3 and T4), and 15 minutes after pneumoconiosis (T5). Hemodynamic variables measured included mean arterial pressure , heart rate , cardiac output, cardiac index, stroke volume index and stroke volume variation. Breathing variables include tidal volume, minute ventilation , respiratory rate , airway frontal pressure , mean airway pressure , plateaus airway pressure , peripheral oxygen saturation , oxygen saturation , and oxygen response . Arterial blood gas variables include pH value, arterial carbon dioxide, arterial oxygen pressure , alkali surplus , alveolar oxygen pressure , and bicarbonate of soda ion concentration .

Primary outcomes

  1. Check the patient's ventilation effect at a specific time

    Time frame: T1(15 minutes after induction of anesthesia)

    we recorded the patients' peak inspiratory pressure

  2. Check the patient's ventilation effect at a specific time

    Time frame: T2(15 minutes after position was changed)

    we recorded the patients' peak inspiratory pressure

  3. Check the patient's ventilation effect at a specific time

    Time frame: T3(30 minutes after pneumoperitoneum was established)

    we recorded the patients' peak inspiratory pressure

  4. Check the patient's ventilation effect at a specific time

    Time frame: T4(60 minutes after pneumoperitoneum was established)

    we recorded the patients' peak inspiratory pressure

  5. Check the patient's ventilation effect at a specific time

    Time frame: T5(15 minutes after pneumoperitoneum was released)

    we recorded the patients' peak inspiratory pressure

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position for Robot-assisted Laparoscopic Urological Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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