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

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Stone; Perioperative/Postoperative Complications
• Intervention / Treatment: Diagnostic test: Preoperative Parameters; Other: Peroperative Parameters; Other: Postoperative Parameters; Other: Movement of kidney; Procedure: single lung ventilation; Procedure: standard 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ömer Faruk Boran; Phone Number: +903442803400; Email: omerfarukboran@hotmail.com

Study Locations

• Turkey
  • Kahramanmaras, Turkey, 46000
    • Recruiting
    • Kahramanmaras Sutcu Imam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Patients given single lung ventilation; 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.	Diagnostic test: Preoperative Parameters; Preoperative Hmg and serum creatinine levels; Other: Peroperative Parameters; Scope duration, perforation, hemorrhage, etc. complications; Other: Postoperative Parameters; Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc; Other: Movement of kidney; Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.; Procedure: single lung ventilation; 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
ACTIVE_COMPARATOR: Patients given standard 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.	Diagnostic test: Preoperative Parameters; Preoperative Hmg and serum creatinine levels; Other: Peroperative Parameters; Scope duration, perforation, hemorrhage, etc. complications; Other: Postoperative Parameters; Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc; Other: Movement of kidney; Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.; Procedure: standard ventilation; Patients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-2 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scope duration	Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.	10-30 Seconds
Total anesthesia duration	Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.	1-2 Hours
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.	1-3 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perop-postop complications	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.	1-2 Days

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): February 20, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: RIRS; Kidney Stone; Single lung ventilation; Simultaneous normal ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Postoperative Complications; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No