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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03999255
Other study ID # ?3/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date May 1, 2018

Study information

Verified date June 2019
Source St. Petersburg State Pavlov Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date May 1, 2018
Est. primary completion date March 3, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
combined respiratory support (CRS)
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.

Locations

Country Name City State
Russian Federation First Pavlov Saint Petersburg Universuty Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
duration of RIRS Surgery
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