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Investigate the Renal Movement by Single Lung Ventilation in Patients Administered RIRS for Kidney Stones.

Primary Purpose

Perioperative/Postoperative Complications, Kidney Stone

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Preoperative Parameters
Peroperative Parameters
Postoperative Parameters
Movement of kidney
single lung ventilation
standard ventilation
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Perioperative/Postoperative Complications focused on measuring RIRS, Kidney Stone, Single lung ventilation, Simultaneous normal ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Older than 18 years
  2. ASA (American Society of Anesthesiologists) 1-3
  3. Patients with 2-3 cm stones in kidneys

Exclusion Criteria:

  1. Patients with staghorn stones in kidneys
  2. Patients with urinary system anomalies

Removal Criteria :

  1. Difficult airway
  2. Patients with carinal, bronchial lesions
  3. Patients with bad general situation
  4. Patients younger than 18 years
  5. Satiated patients

Sites / Locations

  • Kahramanmaraş Sütçü Imam ÜniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients given single lung ventilation

Patients given standard ventilation

Arm Description

The first group will have single lung ventilation applied to ensure reduction. Preoperative Parameters : Hmg, serum creatinine levels Peroperative Parameters : Scope duration, perforation, hemorrhage, etc. complications) Postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc) Movement of kidney : Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

This group will have standard ventilation. Preoperative Parameters : Hmg, serum creatinine levels Peroperative Parameters : Scope duration, perforation, hemorrhage, etc. complications) Postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc) Movement of kidney : Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

Outcomes

Primary Outcome Measures

Changes in renal stone position during ventilation
During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation. Preoperative and postoperative Scope will be used to evolve the renal movement. The values will be recorded in milimeters by comparing it.

Secondary Outcome Measures

Scope duration
Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Total anesthesia duration
Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Hospital stay
During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation and scope durations and brings risks such as perforation during laser lithotripsy application. It may effect hospital stay duration.

Full Information

First Posted
February 17, 2017
Last Updated
February 19, 2020
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT03060837
Brief Title
Investigate the Renal Movement by Single Lung Ventilation in Patients Administered RIRS for Kidney Stones.
Official Title
To Investigate the Effect of Reducing Renal Movement by Single Lung Ventilation in Patients Administered Retrograde Infrarenal Surgery (RIRS) for Kidney Stones on Operative and Postoperative Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam 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
In patients undergoing RIRS for kidney stone, we aim to show the effect of single lung ventilation with a double lumen tube on operative (operation scope duration, perforation, hemorrhage, etc. complications) and postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc.) and to show changes in renal stone position during simultaneous normal ventilation and single lung ventilation.
Detailed Description
In recent years open surgical treatment has changed to minimal invasive treatments for kidney stone treatment. Additionally, the treatment choices vary depending on the localization of the stone and its dimensions. In the European Urology Association (EUA) guidelines, it states the RIRS method can be used to treat stones up to 2 cm in the kidney. Due to RIRS the operation and scopy durations and hospital stay have clearly reduced compared to the standard treatment of percutaneous nephrolithotomy. However, the high hydrostatic pressure applied to the renal pelvis during RIRS may cause unwanted results in the postoperative period such as hydronephrosis and loss of renal parenchyma. During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation and scope durations and brings risks such as perforation during laser lithotripsy application. In this study we aimed to apply single lung ventilation during the operation (one of the indications for single lung ventilation is to increase surgical view and ease manipulation) to minimize renal movement on that side and reduce peroperative and postoperative complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications, Kidney Stone
Keywords
RIRS, Kidney Stone, Single lung ventilation, Simultaneous normal ventilation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients given single lung ventilation
Arm Type
Active Comparator
Arm Description
The first group will have single lung ventilation applied to ensure reduction. Preoperative Parameters : Hmg, serum creatinine levels Peroperative Parameters : Scope duration, perforation, hemorrhage, etc. complications) Postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc) Movement of kidney : Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.
Arm Title
Patients given standard ventilation
Arm Type
Active Comparator
Arm Description
This group will have standard ventilation. Preoperative Parameters : Hmg, serum creatinine levels Peroperative Parameters : Scope duration, perforation, hemorrhage, etc. complications) Postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc) Movement of kidney : Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Preoperative Parameters
Intervention Description
Preoperative Hmg and serum creatinine levels
Intervention Type
Other
Intervention Name(s)
Peroperative Parameters
Intervention Description
Scope duration, perforation, hemorrhage, etc. complications
Intervention Type
Other
Intervention Name(s)
Postoperative Parameters
Intervention Description
Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc
Intervention Type
Other
Intervention Name(s)
Movement of kidney
Intervention Description
Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.
Intervention Type
Procedure
Intervention Name(s)
single lung ventilation
Intervention Description
Patients in this group will intubated with an endotracheal tube and then a bronchial blocker will be placed with the help of a fiberoptic bronchoscope or will be intubated with a double lumen endobronchial tube. One lung ventilation will be applied
Intervention Type
Procedure
Intervention Name(s)
standard ventilation
Intervention Description
Patients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied.
Primary Outcome Measure Information:
Title
Changes in renal stone position during ventilation
Description
During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation. Preoperative and postoperative Scope will be used to evolve the renal movement. The values will be recorded in milimeters by comparing it.
Time Frame
1-2 Hours
Secondary Outcome Measure Information:
Title
Scope duration
Description
Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Time Frame
10-30 Seconds
Title
Total anesthesia duration
Description
Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Time Frame
1-2 Hours
Title
Hospital stay
Description
During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation and scope durations and brings risks such as perforation during laser lithotripsy application. It may effect hospital stay duration.
Time Frame
1-3 Days
Other Pre-specified Outcome Measures:
Title
Perop-postop complications
Description
Single lung ventilation during the operation (one of the indications for single lung ventilation is to increase surgical view and ease manipulation) to minimize renal movement on that side and reduce peroperative and postoperative complications.
Time Frame
1-2 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 18 years ASA (American Society of Anesthesiologists) 1-3 Patients with 2-3 cm stones in kidneys Exclusion Criteria: Patients with staghorn stones in kidneys Patients with urinary system anomalies Removal Criteria : Difficult airway Patients with carinal, bronchial lesions Patients with bad general situation Patients younger than 18 years Satiated patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer Faruk Boran
Phone
+903442803400
Email
omerfarukboran@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Boran
Organizational Affiliation
Kahramanmaraş Üniversitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Kahramanmaraş Sütçü Imam Üniversity
City
Kahramanmaras
ZIP/Postal Code
46000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Boran
Phone
3442803796
Ext
3796
Email
omerfarukboran@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigate the Renal Movement by Single Lung Ventilation in Patients Administered RIRS for Kidney Stones.

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