Randomized clinical trial of comparing the results of routine lumbar puncture (LP) and ultrasound assisted lumbar puncture via emergency physicians in patients referring to emergency department
(1) Objectives: Our aim in this study is to evaluate the role of ultrasound in increasing the rate of success in performing lumbar puncture procedure in patients referring to emergency department. (2) design: In this study, 50 patients referring to Emergency department, Imam Reza Hospital, Tabriz will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent. Patients need a lumbar puncture for definite diagnosis of the disease. (3) Setting and conduct: Patients will be randomly divided to groups of 25. For randomization, we will use computerized randomization with Excel software. Inclusion criteria are age more than 18 years old and the need to perform lumbar puncture for a definite diagnosis of the disease. Exclusion criteria are contraindications for lumbar puncture such as infections in the site, spinal vertebrae malformations and surgeries on vertebrae. (4) Intervention: Patients will be divided into two groups of routine lumbar puncture and real time ultrasound assisted lumbar puncture. In intervention group, the route will be first defined and confirmed by using ultrasound. In the other group lumbar puncture will be performed as routine and without using other instruments. To prevent bias, all lumbar puncture will be done by an emergency resident. (5) Main outcome measures: Time to perform the procedure, success rate, number of tries to perform a successful procedure, rate of complications, rate of picore and drytap will be recorded during and at the end of procedures.
General information
Acronym
LP - Lumbar Puncture
IRCT registration information
IRCT registration number:IRCT2013102511067N3
Registration date:2013-11-06, 1392/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-06, 1392/08/15
Registrant information
Name
Mahboub Pouraghaei
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2078
Email address
pouraghaeim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-09-21, 1392/06/30
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial of comparing the results of routine lumbar puncture (LP) and ultrasound assisted lumbar puncture via emergency physicians in patients referring to emergency department
Public title
Evaluating the effects of using an ancillary method for performing lumbar puncture
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Being more than 18 years old; need to perform a lumbar puncture for definite diagnosis of disease.
Exclusion criteria: Contraindications for lumbar puncture such as infections in the site, spinal vertebrae malformations and surgeries on vertebrae.
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee، Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2013-07-21, 1392/04/30
Ethics committee reference number
7/4/3275
Health conditions studied
1
Description of health condition studied
Lumbar puncture
ICD-10 code
G97
ICD-10 code description
Postprocedural disorders of nervous system, not elsewhere classified
Primary outcomes
1
Description
Time to perform the procedure
Timepoint
At the end of procedure
Method of measurement
By performer of the procedure
2
Description
Number of tries to perform a successful procedure
Timepoint
At the end of procedure
Method of measurement
By performer of the procedure
3
Description
Success rate
Timepoint
At the end of study
Method of measurement
By performer of the procedure
4
Description
rate of drytap
Timepoint
At the end of study
Method of measurement
By performer of the procedure
Secondary outcomes
1
Description
Cerebrospinal fluid leak
Timepoint
At the end of procedure and at the end of study
Method of measurement
By performer of the procedure
Intervention groups
1
Description
In intervention group, route for lumbar puncture will be defined and confirmed by using ultrasound.
Category
Diagnosis
2
Description
In control group, lumbar puncture will be performed as routine.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Moloud Balafar
Street address
Department of Emergency Medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Moloud Balafar
Position
Emergency Medicine resident
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
mbalafar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Emergency Medicine, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahboub Pouraghaei
Position
Assistant Professor/ Specialist in Emergency Medicine
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
pouraghaeim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Moloud Balafar
Position
Emergency Medicine resident
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
Email
mbalafar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)