Kidney; MobileNCT05792670
Can High Ventilation Provide Higher Success Rates in Retrograde Intrarenal Surgery?
A study testing Changing mechanic ventilatation parameters in people with Kidney; Mobile, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
RIRS (Retrograde Intrarenal Surgery) has been accepted as a first-line treatment option for urinary stones smaller than 2 cm and is generally performed under general anesthesia to manipulate respirator-related renal mobility. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Kidney; Mobile
- What is being tested?
- Changing mechanic ventilatation parameters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Apr 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 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent RIRS with kidney stones older than18 y.o
Who cannot join
- Patients younger than 18 years old Patients with a known respiratory disease Patients with a renal anomaly Proximal ureteral stones, or stones with multiple locations The patients who underwent previous ipsilateral percutaneous nephrolithotomy and/or open renal surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can High Ventilation Mode Achieve Higher Success Rates in Retrograde Intrarenal Surgery? Single-Blind Randomized, Prospective, Single-Center Study
RIRS (Retrograde Intrarenal Surgery) has been accepted as a first-line treatment option for urinary stones smaller than 2 cm and is generally performed under general anesthesia to manipulate respirator-related renal mobility. Many surgeons prefer general anesthesia during RIRS to minimize respiration-related renal mobility. Standard mechanical ventilation settings were still inadequate to limit renal mobility and the surgeons tried to find the most effective ventilation mode to minimize renal mobility.
Read the detailed description
A standard general anesthesia protocol is given to all patients by the same anesthesiologist. A Drager Primus (Germany) mechanic ventilator (MV) is preferred for general anesthesia. The MV will determine the tidal volume and respiration frequency according to the patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode is 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume will decrease to 6-8 mL/kg and the frequency will increase to 15-18 respirations/min. No changes are made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters. The ventilation mode of the mechanic ventilator (SV or HV) is determined via randomization software before the surgery. According to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. A high ventilation mode is formed by increasing the respiration frequency and decreasing the study's tidal volume. The aim of the study was to evaluate the effect of this mode on the efficacy and safety of RIRS.
- Conditions
- Kidney; Mobile
- Being tested
- Changing mechanic ventilatation parameters
- Keywords
- renal mobility, urinary stone, mechanic ventilation, success status
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing mechanic ventilatation parametersProcedure or surgery
The tidal volume and respiration frequency were determined by the MV according to patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode was defined as 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume was decreased to 6-8 mL/kg and the frequency was increased to 15-18 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters.
| Study group | Role | What they receive |
|---|---|---|
| Standard Ventilatation Mode | Active comparator | SV mode is defined according to the mechanical ventilator parameters (patients' age and weight) Standard ventilation mode is defined as 8-10 mL/kg tidal volume and 10-15 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters Receives: Procedure: Changing mechanic ventilatation parameters |
| High Ventilatation Mode | Active comparator | Hv mode is defined as the tidal volume decreased to 6-8 mL/kg and the frequency is increased to 15-18 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters Receives: Procedure: Changing mechanic ventilatation parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperatively data of RIRS procedure according to different ventilatation modes
perioperatively data including e.g. operation time
Measured: During the surgical procedure
Complicatation of perioperatively during RIRS
The presence of perioperative bleeding, perioperative bleeding, ureteral perforation, bladder perforation, ureteral avulsion
Measured: During the surgical procedure
Secondary outcomes (2)
Post operative success rates
The stone free status and residue stone volume according to CT
Measured: At the postoperative first month of surgery
Post operative complication
Postoperative complication status including urosepsis, fever, renal colic, flank pain, bleeding and stent migration etc.
Measured: From postoperative first day to postoperative 1. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Jan 2023
- Primary completion25 Feb 2023
- Study completion30 Apr 2023
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 Kidney; MobileStudies of the same condition, open and under way.
- 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
- Model description
- The patients will be divided randomly by a computer-generated randomization table into two equal groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagri DOGAN, Namik Kemal University
- Investigators
- Cagri Dogan, Asst.Prof., Study chair, Namik Kemal UniversityCenk Murat Yazici, Prof.Dr., Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792670
- Sponsor's protocol ID
- 2022.179.10.03
- Status last verified
- Nov 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dogan C, Sahin A, Akgul HM, Yazici CM, Keles A, Ates H, Seramet S. Does High Ventilation Mode Affect the Success Rates of Retrograde Intrarenal Surgery? A Single-Blind Randomized, Prospective, Single-Center Study. J Endourol. 2023 Nov;37(11):1169-1173. doi: 10.1089/end.2023.0303. Epub 2023 Sep 25.
PubMed 37650806
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can High Ventilation Mode Achieve Higher Success Rates in Retrograde Intrarenal Surgery? Single-Blind Randomized, Prospective, Single-Center Study
- ClinicalTrials.gov ID
- NCT05792670
- Acronym / sponsor ID
- 2022.179.10.03
- Conditions
- Kidney; Mobile
- Keywords
- renal mobility, urinary stone, mechanic ventilation, success status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 31 Mar 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.
RIRS (Retrograde Intrarenal Surgery) has been accepted as a first-line treatment option for urinary stones smaller than 2 cm and is generally performed under general anesthesia to manipulate respirator-related renal mobility. Many surgeons prefer general anesthesia during RIRS to minimize respiration-related renal mobility. Standard mechanical ventilation settings were still inadequate to limit renal mobility and the surgeons tried to find the most effective ventilation mode to minimize renal mobility.
Detailed description
A standard general anesthesia protocol is given to all patients by the same anesthesiologist. A Drager Primus (Germany) mechanic ventilator (MV) is preferred for general anesthesia. The MV will determine the tidal volume and respiration frequency according to the patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode is 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume will decrease to 6-8 mL/kg and the frequency will increase to 15-18 respirations/min. No changes are made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters. The ventilation mode of the mechanic ventilator (SV or HV) is determined via randomization software before the surgery. According to randomization, the anesthesiologist is informed about the ventilation mode but the surgeons are absolutely blind. A high ventilation mode is formed by increasing the respiration frequency and decreasing the study's tidal volume. The aim of the study was to evaluate the effect of this mode on the efficacy and safety of RIRS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The patients will be divided randomly by a computer-generated randomization table into two equal groups.
| Arm | Type | Receives |
|---|---|---|
| Standard Ventilatation Mode | Active comparator | Procedure: Changing mechanic ventilatation parametersSV mode is defined according to the mechanical ventilator parameters (patients' age and weight) Standard ventilation mode is defined as 8-10 mL/kg tidal volume and 10-15 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters |
| High Ventilatation Mode | Active comparator | Procedure: Changing mechanic ventilatation parametersHv mode is defined as the tidal volume decreased to 6-8 mL/kg and the frequency is increased to 15-18 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent RIRS with kidney stones older than18 y.o
Key exclusion criteria (1 listed)
- Patients younger than 18 years old Patients with a known respiratory disease Patients with a renal anomaly Proximal ureteral stones, or stones with multiple locations The patients who underwent previous ipsilateral percutaneous nephrolithotomy and/or open renal surgery were excluded from the study.
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 |
|---|---|---|
| Changing mechanic ventilatation parametersThe tidal volume and respiration frequency were determined by the MV according to patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode was defined as 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume was decreased to 6-8 mL/kg and the frequency was increased to 15-18 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters. | Procedure or surgery | High Ventilatation Mode, Standard Ventilatation Mode |
Primary outcome
perioperatively data of RIRS procedure according to different ventilatation modes
Time frame: During the surgical procedure
perioperatively data including e.g. operation time
Complicatation of perioperatively during RIRS
Time frame: During the surgical procedure
The presence of perioperative bleeding, perioperative bleeding, ureteral perforation, bladder perforation, ureteral avulsion
2 secondary outcomes
Post operative success rates
Time frame: At the postoperative first month of surgery
Post operative complication
Time frame: From postoperative first day to postoperative 1. month
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 13 Nov 2023.
- Derived from this study: PubMed 37650806Dogan C, Sahin A, Akgul HM, Yazici CM, Keles A, Ates H, Seramet S. Does High Ventilation Mode Affect the Success Rates of Retrograde Intrarenal Surgery? A Single-Blind Randomized, Prospective, Single-Center Study. J Endourol. 2023 Nov;37(11):1169-1173. doi: 10.1089/end.2023.0303. Epub 2023 Sep 25.
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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.
Cagri Dogan, Asst.Prof. study chair
Namik Kemal University
Cenk Murat Yazici, Prof.Dr. principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changing mechanic ventilatation parameters in people with Kidney; Mobile, run by Namik Kemal 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 1 inclusion and 1 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 13 Nov 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 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?
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?
perioperatively data of RIRS procedure according to different ventilatation modes (time frame: During the surgical procedure). The study lists 2 primary outcomes in all. 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 NCT05792670, 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 13 Nov 2023.