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

Not Applicable

• Conditions: Kidney Stone; Perioperative/Postoperative Complications
• Interventions: Diagnostic Test: Preoperative Parameters; Other: Peroperative Parameters; Other: Postoperative Parameters; Other: Movement of kidney; Procedure: single lung ventilation; Procedure: standard ventilation

• Registration Number: NCT03060837
• Lead Sponsor: Kahramanmaras Sutcu Imam University

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.

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Study Start: 2017-03-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Primary Completion: 2020-02-20
• Last Update Posted: 2020-02-20
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients given standard ventilation	Preoperative Parameters	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.
Patients given standard ventilation	Peroperative Parameters	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.
Patients given single lung ventilation	Peroperative Parameters	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.
Patients given single lung ventilation	Postoperative Parameters	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.
Patients given single lung ventilation	Movement of kidney	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.
Patients given single lung ventilation	Preoperative Parameters	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.
Patients given standard ventilation	Movement of kidney	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.
Patients given single lung ventilation	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.
Patients given standard ventilation	Postoperative Parameters	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.
Patients given standard ventilation	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.

Primary Outcome Measures

Name	Time	Method
Changes in renal stone position during ventilation	1-2 Hours	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

Name	Time	Method
Total anesthesia duration	1-2 Hours	Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Scope duration	10-30 Seconds	Movement of the kidney during the procedure may cause peroperative complications and lengthen operation and scope durations.
Hospital stay	1-3 Days	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.

Trial Locations

Locations (1)

Kahramanmaraş Sütçü Imam Üniversity; 🇹🇷 Kahramanmaras, Turkey