Prostate CancerNCT03740854
The Effects of Two Different Ventilation Strategies on Lung Ventilation: An Ultrasonographic Evaluation.
A study of Prostate Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study will be performed in robotic assisted laparoscopic radical prostatectomy patients in Cerrahpasa Medical Faculty Monoblock Operating Room. Since robot-assisted laparoscopic radical prostatectomy is a surgical procedure which requires long-term mechanical ventilation, excessive trendelenburg position (30-45… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2018to 1 Jul 2020
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who will be undergo robot assisted laparoscopic prostatectomy surgery
- Patient with ASA (American Society of Anesthesiologists) Score 1-3
Who cannot join
- Patients with ASA Score above 3
- Patients with obstructive (FEV1<%60) or restrictive pulmonary disease (FVC<%60)
- Patients with intrathoracic operation history
- Heavy smokers (>25 cigarettes/day)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medical Faculty of Cerrahpasa
Istanbul
Hacer Zeynep Turgut, MD, +905057859922, drzturgut@gmail.com
Fatis Altintas, MD, +905337785278, fatisaltintas@yahoo.com
About this study
Official title: The Effects of Two Different Ventilation Strategies on Lung Ventilation in Patients Undergoing Robotic Radical Prostatectomy: Ultrasonographic Evaluation.
This study will be performed in robotic assisted laparoscopic radical prostatectomy patients in Cerrahpasa Medical Faculty Monoblock Operating Room. Since robot-assisted laparoscopic radical prostatectomy is a surgical procedure which requires long-term mechanical ventilation, excessive trendelenburg position (30-45 °) and pneumoperitoneum; these interventions may lead to respiratory complications such as ventilation difficulty and aeration loss in patients. Nowadays, lung ultrasonography has been used in anesthesia practice and intensive care units in order to determine lung aeration loss. In this study, the investigators aimed to compare the possible aeration loss in lung parenchyma during pressure controlled ventilation and volume controlled ventilation which are frequently used in anesthesia practice in patients undergoing robotic radical prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Pressure Controlled Ventilation, Volume Controlled Ventilation
- Keywords
- lung ultrasonography, mechanical ventilation, pressure controlled ventilation, volume controlled ventilation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Controlled VentilationOther
Patients will be ventilated with a pressure level which supplies a tidal volume corresponding 8ml/kg, 12 breaths per minute, 1/2 inspiration/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.
Volume Controlled VentilationOther
Patients will be ventilated with a tidal volume which corresponds 8ml/kg, 12 breaths per minute, 1/2 inspirastion/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.
| Study group | Role | What they receive |
|---|---|---|
| Pressure Controlled Ventilation | Active comparator | Patients undergoing pressure controlled ventilation Receives: Other: Pressure Controlled Ventilation |
| Volume Controlled Ventilation | Active comparator | Patients undergoing volume controlled ventilation Receives: Other: Volume Controlled Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between LUS Scores at T5 in patients ventilated with VCV and PCV
Lung Ultrasonography will be applied to patients after surgery in the recovery room at T5. Two different groups' LUS scores will be calculated and compared.
Measured: (T5) 60 minutes after patients come to the recovery room.
Secondary outcomes (3)
The difference between LUS Scores at T2 in patients ventilated with VCV and PCV
Lung Ultrasonography will be applied to patients after intubation. Two different groups' LUS scores will be calculated and compared.
Measured: (T2) 5 minutes after intubation
The difference between LUS Scores at T3 in patients ventilated with VCV and PCV
Lung Ultrasonography will be applied to patients at Trendelenburg position after the surgical prosedure is finished. Two different groups' LUS scores will be calculated and compared.
Measured: (T3) 5 minutes after the surgical procedure is finished
The difference between LUS Scores at T4 in patients ventilated with VCV and PCV
Lung Ultrasonography will be applied to patients at supin position after the surgical prosedure is finished. Two different groups' LUS scores will be calculated and compared.
Measured: (T4) 5 minutes after taking the patient to supin position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start4 Dec 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Zeynep Turgut, Istanbul University
- Investigators
- Fatis Altintas, MD, Study director, Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740854
- Sponsor's protocol ID
- 68839
- Status last verified
- Feb 2019
- First submitted
- 12 Nov 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Different Ventilation Strategies on Lung Ventilation in Patients Undergoing Robotic Radical Prostatectomy: Ultrasonographic Evaluation.
- ClinicalTrials.gov ID
- NCT03740854
- Acronym / sponsor ID
- 68839
- Conditions
- Prostate Cancer
- Keywords
- lung ultrasonography, mechanical ventilation, pressure controlled ventilation, volume controlled ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 14 Nov 2018 (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.
This study will be performed in robotic assisted laparoscopic radical prostatectomy patients in Cerrahpasa Medical Faculty Monoblock Operating Room. Since robot-assisted laparoscopic radical prostatectomy is a surgical procedure which requires long-term mechanical ventilation, excessive trendelenburg position (30-45 °) and pneumoperitoneum; these interventions may lead to respiratory complications such as ventilation difficulty and aeration loss in patients. Nowadays, lung ultrasonography has been used in anesthesia practice and intensive care units in order to determine lung aeration loss. In this study, the investigators aimed to compare the possible aeration loss in lung parenchyma during pressure controlled ventilation and volume controlled ventilation which are frequently used in anesthesia practice in patients undergoing robotic radical prostatectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure Controlled Ventilation | Active comparator | Other: Pressure Controlled VentilationPatients undergoing pressure controlled ventilation |
| Volume Controlled Ventilation | Active comparator | Other: Volume Controlled VentilationPatients undergoing volume controlled ventilation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient who will be undergo robot assisted laparoscopic prostatectomy surgery
- Patient with ASA (American Society of Anesthesiologists) Score 1-3
Key exclusion criteria (4 listed)
- Patients with ASA Score above 3
- Patients with obstructive (FEV1<%60) or restrictive pulmonary disease (FVC<%60)
- Patients with intrathoracic operation history
- Heavy smokers (>25 cigarettes/day)
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 |
|---|---|---|
| Pressure Controlled VentilationPatients will be ventilated with a pressure level which supplies a tidal volume corresponding 8ml/kg, 12 breaths per minute, 1/2 inspiration/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels. | Other | Pressure Controlled Ventilation |
| Volume Controlled VentilationPatients will be ventilated with a tidal volume which corresponds 8ml/kg, 12 breaths per minute, 1/2 inspirastion/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels. | Other | Volume Controlled Ventilation |
Primary outcome
The difference between LUS Scores at T5 in patients ventilated with VCV and PCV
Time frame: (T5) 60 minutes after patients come to the recovery room.
Lung Ultrasonography will be applied to patients after surgery in the recovery room at T5. Two different groups' LUS scores will be calculated and compared.
3 secondary outcomes
The difference between LUS Scores at T2 in patients ventilated with VCV and PCV
Time frame: (T2) 5 minutes after intubation
The difference between LUS Scores at T3 in patients ventilated with VCV and PCV
Time frame: (T3) 5 minutes after the surgical procedure is finished
The difference between LUS Scores at T4 in patients ventilated with VCV and PCV
Time frame: (T4) 5 minutes after taking the patient to supin position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Fatis Altintas, MD study director
Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Prostate Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hacer Zeynep Turgut, MD (+905057859922, drzturgut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between LUS Scores at T5 in patients ventilated with VCV and PCV (time frame: (T5) 60 minutes after patients come to the recovery room.). 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 27 Feb 2019.