Mechanical VentilationNCT06056401
Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position
A study testing record Hemodynamic variables, respiratory variables and arterial blood gas at specific times in people with Mechanical Ventilation and General Anesthesia, run by Sun Yat-sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation, General Anesthesia, Urological Surgery
- What is being tested?
- record Hemodynamic variables, respiratory variables and arterial blood gas at specific times
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2022to 24 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing urological surgery in clasp-knife position
- between the age of 18 and 65
- America Society of Anesthesiologist Grades I-II.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position for Robot-assisted Laparoscopic Urological Surgery
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.
Read the detailed description
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.
- Being tested
- record Hemodynamic variables, respiratory variables and arterial blood gas at specific times
- Keywords
- Mechanical ventilation, robot-assisted surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
record Hemodynamic variables, respiratory variables and arterial blood gas at specific timesBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| VCV group | Experimental | For patients assigned in this group, after standard anesthesia, in which the following drugs were used (midazolam 0.05 mg / kg;propofol 1.5-2.5 mg / kg; sufentanil 0.3-0.5 μg / kg; and cisatracurium0.2-0.3 mg / kg), their mechanical ventilation mode was adjusted to the VCV mode. Receives: Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific times |
| PCV group | Experimental | For patients assigned in this group, after standard anesthesia, in which the following drugs were used (midazolam 0.05 mg / kg;propofol 1.5-2.5 mg / kg; sufentanil 0.3-0.5 μg / kg; and cisatracurium0.2-0.3 mg / kg), their mechanical ventilation mode was adjusted to the PCV mode. Receives: Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Check the patient's ventilation effect at a specific time
we recorded the patients' peak inspiratory pressure
Measured: T1(15 minutes after induction of anesthesia)
Check the patient's ventilation effect at a specific time
we recorded the patients' peak inspiratory pressure
Measured: T2(15 minutes after position was changed)
Check the patient's ventilation effect at a specific time
we recorded the patients' peak inspiratory pressure
Measured: T3(30 minutes after pneumoperitoneum was established)
Check the patient's ventilation effect at a specific time
we recorded the patients' peak inspiratory pressure
Measured: T4(60 minutes after pneumoperitoneum was established)
Check the patient's ventilation effect at a specific time
we recorded the patients' peak inspiratory pressure
Measured: T5(15 minutes after pneumoperitoneum was released)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Oct 2022
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Xinyuan, Sun Yat-sen University
- Investigators
- Wenqian Lin, Principal investigator, anesthesiology department of Sun Yat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056401
- Sponsor's protocol ID
- 2022-FXY-282
- Status last verified
- Sep 2023
- First submitted
- 8 Mar 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Volume-controlled and Pressure-controlled Ventilation in Clasp-knife Position for Robot-assisted Laparoscopic Urological Surgery
- ClinicalTrials.gov ID
- NCT06056401
- Acronym / sponsor ID
- 2022-FXY-282
- Keywords
- Mechanical ventilation, robot-assisted surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VCV group | Experimental | Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific timesFor patients assigned in this group, after standard anesthesia, in which the following drugs were used (midazolam 0.05 mg / kg;propofol 1.5-2.5 mg / kg; sufentanil 0.3-0.5 μg / kg; and cisatracurium0.2-0.3 mg / kg), their mechanical ventilation mode was adjusted to the VCV mode. |
| PCV group | Experimental | Behavioral: record Hemodynamic variables, respiratory variables and arterial blood gas at specific timesFor patients assigned in this group, after standard anesthesia, in which the following drugs were used (midazolam 0.05 mg / kg;propofol 1.5-2.5 mg / kg; sufentanil 0.3-0.5 μg / kg; and cisatracurium0.2-0.3 mg / kg), their mechanical ventilation mode was adjusted to the PCV mode. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing urological surgery in clasp-knife position
- between the age of 18 and 65
- America Society of Anesthesiologist Grades I-II.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| record Hemodynamic variables, respiratory variables and arterial blood gas at specific timesHemodynamic 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 . | Behavioural | PCV group, VCV group |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenqian Lin principal investigator
anesthesiology department of Sun Yat-sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing record Hemodynamic variables, respiratory variables and arterial blood gas at specific times in people with Mechanical Ventilation and General Anesthesia, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Check the patient's ventilation effect at a specific time (time frame: T1(15 minutes after induction of anesthesia)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.