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Effects of pre-bronchoscopy administration of intravenous hydrocortisone in patients with chronic obstructive pulmonary disease: A randomized, double blind, placebo controlled trial

Protocol summary

Summary
(1)Objectives;Effects of pre-bronchoscopy administration of intravenous hydrocortisone in patients with chronic obstructive pulmonary disease (2) Design: A double blind, single center, clinical trial design will conduct in 90 patients with COPD. Random assignment of subjects in both intervention and control groups will categorize(blocking). (3) Setting and conduct; 90 patients with COPD that need bronchoscopy, will divide randomly to two groups (intervention and control groups) and after signing permission form ,underwent bronchoscopy (5) Intervention ;Neither physicians, nurses or patients know which patient is located either in intervention or control group. In each of the intervention and control groups,the Fhberoptic Bronchoscopy( FB) will performe and the measurement of PFT , Hemogolobin oxygen saturation, cough score and vital signs will record on a validated self made checklist before and after procedure. In intervention group intravenous hydrocortisone 200 mg in 5 ml, and for the subjects of the control group, the same volume of saline, will administer 2 hours befor FB . finally results will compare between two groups. (6) main outcome measures;primary outcome variables included, PFT, vital signs, Hemoglobin oxygen saturation and cough severity. we do not have secondary variable outcome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110922566N1
Registration date: 2015-12-30, 1394/10/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-30, 1394/10/09
Registrant information
Name
Seyed Mehdi Hashemi Bajgani
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 8078
Email address
m_hashemi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Kerman University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pre-bronchoscopy administration of intravenous hydrocortisone in patients with chronic obstructive pulmonary disease: A randomized, double blind, placebo controlled trial
Public title
Effects of pre-bronchoscopy administration of intravenous hydrocortisone in patients with chronic obstructive pulmonary disease
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria; " diagnosed with chronic obstructive pulmonary disease and FEV1/FVC ratio less than 70%" " history of smoking" "the need of bronchoscopy for the diagnostic studies like hemoptysis, tuberculosis or lung mass". exclusion criteria; "diagnosis of asthma,cystic fibrosis" " oral or intravenous corticosteroid therapy or inhaled corticosteroid dose of 600 micrograms or more per day" " therapeutic bronchoscopy" " intubation".
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Jomhouri Islami Blv, Central Organization
City
kerman
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
52/92/ک

Health conditions studied

1

Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J40, J41,
ICD-10 code description
chronic lower respiratory diseases

Primary outcomes

1

Description
vital sign
Timepoint
pre-bronchoscopy and 1 hour after bronchoscopy
Method of measurement
termometer,choronometer,sphygmanometer

2

Description
cough
Timepoint
pre-bronchoscopy and 1 hour after bronchoscopy
Method of measurement
numboring score from 1 to 10

3

Description
spirometery
Timepoint
pre-bronchoscopy and 1 hour after bronchoscopy
Method of measurement
spirometer

4

Description
saturaton of blood oxygen
Timepoint
pre-bronchoscopy and 1 hour after bronchoscopy
Method of measurement
pulseoxymeter

Secondary outcomes

empty

Intervention groups

1

Description
200 mg hydrocortisone diluted in 10 cc iv 2 hour before bronchoscopy
Category
Treatment - Drugs

2

Description
10 cc normal salin iv 2 hour before bronchoscopy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Dr. Seyedmehdi Hashemi
Street address
Imam Highway ,Afzalipour Hospital
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Kerman University of Medical Sciences
Full name of responsible person
DR.Abbas Pardakhti
Street address
Jahad Blv.Vice chancellor for research,Kerman University of Medical Sciences
City
kerman
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,Kerman 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
kerman University of Medical Science
Full name of responsible person
Dr. Seyedmehdi Hashemibajgani
Position
Assistant Professor
Other areas of specialty/work
Street address
Jomhoori Islami Blv, University Central Organization
City
kerman
Postal code
7618759689
Phone
+98 34 3121 5600
Fax
+98 34 3325 7477
Email
kmu_research@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
kerman University of Medical Science
Full name of responsible person
Dr.Seyedmehdi Hashemibajgani
Position
Assistant Professor
Other areas of specialty/work
Street address
Jomhouri Islami Blv, University Central Organization
City
kerman
Postal code
7618759689
Phone
+98 34 3121 5600
Fax
+98 34 3325 7477
Email
kmu_research@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Seyedmehdi Hashemibajgani
Position
Assistant Professor
Other areas of specialty/work
Street address
Jomhouri Islami Blv.Central organization
City
Kerman
Postal code
7618759689
Phone
+98 34 3211 8078
Fax
+98 34 3325 7477
Email
m_hashemi@kmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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