NCT03060837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

February 17, 2017

Last Update Submit

February 19, 2020

Conditions

Perioperative/Postoperative ComplicationsKidney Stone

Keywords

RIRSKidney StoneSingle lung ventilationSimultaneous normal ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Scope duration

    10-30 Seconds

  • Total anesthesia duration

    1-2 Hours

  • Hospital stay

    1-3 Days

Other Outcomes (1)

  • Perop-postop complications

    1-2 Days

Study Arms (2)

Patients given single lung ventilation

ACTIVE COMPARATOR

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 ParametersOther: Peroperative ParametersOther: Postoperative ParametersOther: Movement of kidneyProcedure: single lung ventilation

Patients given standard ventilation

ACTIVE COMPARATOR

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 ParametersOther: Peroperative ParametersOther: Postoperative ParametersOther: Movement of kidneyProcedure: standard ventilation

Interventions

Preoperative ParametersDIAGNOSTIC_TEST

Preoperative Hmg and serum creatinine levels

Patients given single lung ventilationPatients given standard ventilation
Peroperative ParametersOTHER

Scope duration, perforation, hemorrhage, etc. complications

Patients given single lung ventilationPatients given standard ventilation
Postoperative ParametersOTHER

Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc

Patients given single lung ventilationPatients given standard ventilation
Movement of kidneyOTHER

Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

Patients given single lung ventilationPatients given standard ventilation
single lung ventilationPROCEDURE

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

Patients given single lung ventilation
standard ventilationPROCEDURE

Patients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied.

Patients given standard ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü Imam Üniversity

Kahramanmaraş, 46000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative ComplicationsKidney Calculi

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Study Officials

  • Ömer Faruk Boran

    Kahramanmaraş Üniversitesi

    STUDY CHAIR

Central Study Contacts

Ömer Faruk Boran

CONTACT

+903442803400omerfarukboran@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 23, 2017

Study Start

March 1, 2017

Primary Completion

February 20, 2020

Study Completion

March 1, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)