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Effects of prewarming on preventing early intraoperative hypothermia during percutaneous nephrolithotomy under general anesthesia: a randomized controlled trial

Status Approved

First Submitted Date

2021/02/22
Registered Date

2021/03/08
Last Updated Date

2022/01/09

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005969
Unique Protocol ID	KC21EISI0010
Public/Brief Title	Effects of prewarming on preventing early intraoperative hypothermia during percutaneous nephrolithotomy under general anesthesia: a randomized controlled trial
Scientific Title	Effects of prewarming on preventing early intraoperative hypothermia during percutaneous nephrolithotomy under general anesthesia: a randomized controlled trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC21EISI0010
Approval Date	2021-02-09
Institutional Review Board Name	Institutional Review Board and Ethics Committee of Seoul St. Mary’s Hospital
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jung-Woo Shim
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul
Contact Person for Public Queries
Name	Jung-Woo Shim
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul
Contact Person for Updating Information
Name	Jung-Woo Shim
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222, Banpo-daero, Seocho-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2022-01-12 Anticipated
Target Number of Participant	68
Primary Completion Date
Study Completion Date
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2022-01-12 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	There has been a concern about hypothermia during percutaneous nephrolithotomy under general anesthesia, resulting from large amounts of irrigation fluid for operation. Several studies reported that the use of irrigation fluid with room temperature significantly reduced postoperative recovery time, hypothermia, and shivering. Despite this effort, most of the patients still showed intraoperative hypothermia. On the other hand, several literatures revealed that 10-min prewarming before surgery significantly reduced the incidence of hypothermia during other operations. We sought to demonstrate that prewarming was effective in reducing early intraoperative hypothermia during percutaneous nephrolithotomy.

Study Summary Information

Lay Summary

There has been a concern about hypothermia during percutaneous nephrolithotomy under general anesthesia, resulting from large amounts of irrigation fluid for operation. Several studies reported that the use of irrigation fluid with room temperature significantly reduced postoperative recovery time, hypothermia, and shivering. Despite this effort, most of the patients still showed intraoperative hypothermia.
On the other hand, several literatures revealed that 10-min prewarming before surgery significantly reduced the incidence of hypothermia during other operations. We sought to demonstrate that prewarming was effective in reducing early intraoperative hypothermia during percutaneous nephrolithotomy.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Behavioral
Intervention Description	In the experimental group, prewarming is performed during 10 min in the preoperative unit. The patients are prewarmed using a forced-air blanket positioned over the body and connected to a forced-air warmer (Bair-Hugger). Temperature output of the warmer is set at 43 °C. In the control group, patients are given blanket positioned over the body, but prewarming is not performed in the preoperative unit. The core temperatures during the surgery are measured every 15 min, using esophageal temperature probes. In every patient, intraoperative warming is performed using a forced-air blanket warmed with Bair-Hugger set at 38 °C.
Number of Arms	2
Arm 1	Arm Label The experimental group
	Target Number of Participant 34
	Arm Type Experimental
	Arm Description In the experimental group, prewarming is performed during 10 min in the preoperative unit. The patients are prewarmed using a forced-air blanket positioned over the body and connected to a forced-air warmer (Bair-Hugger). Temperature output of the warmer is set at 43 °C.
Arm 2	Arm Label The control group
	Target Number of Participant 34
	Arm Type No intervention
	Arm Description In the control group, patients are given blanket positioned over the body, but prewarming is not performed in the preoperative unit.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N21.9)Calculus of lower urinary tract, unspecified Urinary Calculi
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~79Year
	Description ASA (American Society of Anesthesiologists) physical status classification 1 or 2
Exclusion Criteria	1. Patients who do not agree to participate in this study 2. Emergency surgery 3. Intraoperative hemodynamic instability with the extent that vasoactive drugs are necessary 4. Performing ureteroscopic lithotripsy instead of planned percutaneous nephrolithotomy
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Incidence of early hypothermia during surgery (<36 °C)
Timepoint	during the first hour after surgery begins
Secondary Outcome(s) 1
Outcome	Cumulative degree of intraoperative temperature change
Timepoint	every 15 min during surgery (area under curve for operating period)
Secondary Outcome(s) 2
Outcome	Postoperative shivering
Timepoint	postoperative period
Secondary Outcome(s) 3
Outcome	Postoperative opioid requirement
Timepoint	postoperative period
Secondary Outcome(s) 4
Outcome	Postoperative complications
Timepoint	postoperative period

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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