SEARCH FOR OPTIMAL ANAESTHESIA IN RETROGRADE INTRARENAL SURGERY
Primary Purpose
Kidney Stone
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
combined respiratory support (CRS)
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone
Eligibility Criteria
Inclusion Criteria:
- Kidneys stones with indications for retrograde intrarenal surgery
Exclusion Criteria:
- Patients with ASA class of greater than 3
- Patients with active urinary tract infection were excluded from the study
Sites / Locations
- First Pavlov Saint Petersburg Universuty
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients undergoing intrarenal surgery
Arm Description
Outcomes
Primary Outcome Measures
Kidney motion assessed by the endourologist during retrograde intrarenal surgery
a questionnaire was implemented in order to assess surgeon's feedback on novel technique. This was done in 2-step fashion in every patient and each patient served his own control: first, after the beginning of GA with MV in the mode of normal ventilation the questionnaire was implemented and surgeons were asked to assess the mobility of the operative field and the decency of conditions for laser lithotripsy.
Second, novel CRS technique was then instituted and maintained throughout RIRS. Before lithotripsy itself surgeons were once again asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the previously mentioned questionnaire.
Secondary Outcome Measures
Full Information
NCT ID
NCT03999255
First Posted
June 23, 2019
Last Updated
June 25, 2019
Sponsor
St. Petersburg State Pavlov Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03999255
Brief Title
SEARCH FOR OPTIMAL ANAESTHESIA IN RETROGRADE INTRARENAL SURGERY
Official Title
REDUCING KIDNEY MOTION: OPTIMIZING ANESTHESIA AND COMBINING RESPIRATORY SUPPORT FOR RETROGRADE INTRARENAL SURGERY: A PILOT STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 3, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing retrograde intrarenal surgery for kidney stones from November 2017 to May 2018 were prospectively recruited to participate in the study. In each case after the beginning of general anesthesia with mechanical ventilation surgeons were asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the developed questionnaire scale. The questionnaire consisted of 5 degrees of assessment of kidney mobility and each question was scored from 1 to 5, 1 being very mobile (extremely poor conditions for dusting) and 5 completely immobile (Ideal conditions for dusting). After this assessment modified technique of general anesthesia was applied called combined respiratory support which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high frequency jet ventilation through endotracheal tube with a respiratory cycle frequency of 300 per minute and maintained during retrograde intrarenal surgery. At the beginning of combined respiratory approach, surgeons were once again asked to assess the mobility of the operative field and the conditions for laser lithotripsy. Main ventilation parameters were recorded and compared in both regimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing intrarenal surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
combined respiratory support (CRS)
Intervention Description
combined respiratory support (CRS) which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high-frequency jet ventilation (HFJV) through an endotracheal tube with a respiratory cycle frequency (RCF) of 300 per minute and maintained during RIRS.
Primary Outcome Measure Information:
Title
Kidney motion assessed by the endourologist during retrograde intrarenal surgery
Description
a questionnaire was implemented in order to assess surgeon's feedback on novel technique. This was done in 2-step fashion in every patient and each patient served his own control: first, after the beginning of GA with MV in the mode of normal ventilation the questionnaire was implemented and surgeons were asked to assess the mobility of the operative field and the decency of conditions for laser lithotripsy.
Second, novel CRS technique was then instituted and maintained throughout RIRS. Before lithotripsy itself surgeons were once again asked to assess the mobility of the operative field and conditions for laser lithotripsy according to the previously mentioned questionnaire.
Time Frame
duration of RIRS Surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Kidneys stones with indications for retrograde intrarenal surgery
Exclusion Criteria:
Patients with ASA class of greater than 3
Patients with active urinary tract infection were excluded from the study
Facility Information:
Facility Name
First Pavlov Saint Petersburg Universuty
City
Saint Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31277626
Citation
Gadzhiev N, Oibolatov U, Kolotilov L, Parvanyan S, Akopyan G, Petrov S, Cottone CM, Sung J, Okhunov Z. Reducing kidney motion: optimizing anesthesia and combining respiratory support for retrograde intrarenal surgery: a pilot study. BMC Urol. 2019 Jul 5;19(1):61. doi: 10.1186/s12894-019-0491-3.
Results Reference
derived
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SEARCH FOR OPTIMAL ANAESTHESIA IN RETROGRADE INTRARENAL SURGERY
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