Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General AnesthesiaNCT02803424
Comparison of Volume Controlled Ventilation and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
A study of Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak pressure. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Dec 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia
Who cannot join
- chronic obstructive respiratory diseases
- heart failure
- body mass index (BMI >30 kg/m2)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Seoul, Seoul, 03722
About this study
The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.
- Being tested
- Volume controlled ventilation, Autoflow-volume controlled ventilation
- Keywords
- robot-assisted laparoscopic radical prostatectomy, Autoflow, trendelenburg position, pneumoperitoneum
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume controlled ventilationOther
Also called VCV
During anesthesia and surgical procedure, volume-controlled ventilation will be applied with an inspiration:expiration ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg) without ventilatory mode change.
Autoflow-volume controlled ventilationOther
Also called Autoflow-VCV
After tracheal intubation, volume-controlled ventilation will be initiated with an I:E ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg). Immediately after CO2 pneumoperitoneum with steep Trendelenburg positioning, Autoflow-volume controlled ventilation will be applied instead of volume-controlled ventilation. Immediately after CO2 desufflation and supine positioning, volume-controlled ventilation will be applied again.
| Study group | Role | What they receive |
|---|---|---|
| Volume controlled ventilation | Experimental | During the steep trendelenburg position and pneumoperitoneum, volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2. Receives: Other: Volume controlled ventilation |
| Autoflow-volume controlled ventilation | Active comparator | During the steep trendelenburg position and pneumoperitoneum, Autoflow-volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2. Receives: Other: Autoflow-volume controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygen tension (PaO2)
Arterial oxygen tension (PaO2) obtained from arterial blood gas analysis
Measured: 30 minutes after steep trendelenburg position and pneumoperitoneum.
Secondary outcomes (1)
The peak inspiratory pressure
The peak inspiratory pressure during mechanical ventilation with endotracheal intubation under general anesthesia
Measured: 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803424
- Sponsor's protocol ID
- 4-2016-0311
- Status last verified
- Dec 2016
- First submitted
- 9 Jun 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no plan to share data
Publications
Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.
PubMed 25869025
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Volume Controlled Ventilation and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
- ClinicalTrials.gov ID
- NCT02803424
- Acronym / sponsor ID
- 4-2016-0311
- Keywords
- robot-assisted laparoscopic radical prostatectomy, Autoflow, trendelenburg position, pneumoperitoneum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Autoflow-volume controlled ventilation may improve lung compliance and reduce airway peak pressure. Therefore, the aim of this study is to evaluate whether Autoflow-volume controlled ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volume controlled ventilation | Experimental | Other: Volume controlled ventilationDuring the steep trendelenburg position and pneumoperitoneum, volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2. |
| Autoflow-volume controlled ventilation | Active comparator | Other: Autoflow-volume controlled ventilationDuring the steep trendelenburg position and pneumoperitoneum, Autoflow-volume controlled ventilation will be applied with 8ml/kg (ideal body weight) and inspiration:expiration ratio (I:E) = 1:2. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult male patients scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia
Key exclusion criteria (3 listed)
- chronic obstructive respiratory diseases
- heart failure
- body mass index (BMI >30 kg/m2)
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 |
|---|---|---|
| Volume controlled ventilationAlso: VCVDuring anesthesia and surgical procedure, volume-controlled ventilation will be applied with an inspiration:expiration ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg) without ventilatory mode change. | Other | Volume controlled ventilation |
| Autoflow-volume controlled ventilationAlso: Autoflow-VCVAfter tracheal intubation, volume-controlled ventilation will be initiated with an I:E ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg). Immediately after CO2 pneumoperitoneum with steep Trendelenburg positioning, Autoflow-volume controlled ventilation will be applied instead of volume-controlled ventilation. Immediately after CO2 desufflation and supine positioning, volume-controlled ventilation will be applied again. | Other | Autoflow-volume controlled ventilation |
Primary outcome
arterial oxygen tension (PaO2)
Time frame: 30 minutes after steep trendelenburg position and pneumoperitoneum.
Arterial oxygen tension (PaO2) obtained from arterial blood gas analysis
1 secondary outcome
The peak inspiratory pressure
Time frame: 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation.
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 Dec 2016.
- Background: PubMed 25869025Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.
- Individual participant dataSharing planned: No. no plan to share data
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Robot-assisted Laparoscopic Radical Prostatectomy Undergoing General Anesthesia, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 3 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 Dec 2016. 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 South Korea. 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?
arterial oxygen tension (PaO2) (time frame: 30 minutes after steep trendelenburg position and pneumoperitoneum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803424, which also lists 1 linked publication.
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 Dec 2016.