Protocol summary

Summary
The purpose of this study is the prevention of pulmonary complications in 225 heavy smokers with normal spirometry, age 35-65 years with American Society of Anesthesiologists (ASA) (I- II- III) and no respiratory symptoms after Coronary artery bypass grafting (CABG). Patients divided into 3 groups. We strongly recommend stopping smoking eight weeks before surgery to all groups. Group 1, smokers have not been treated but smoked before surgery. Groups 2, smokers have been treated with Salbutamol_Atrovent_ Beclometazon 10-14 days before surgery and still have smoked before surgery. Groups 3, smokers have quit smoking for 8 weeks. Inclusion criteria: Heavy smokers (20 pack-year); normal spirometry. Exclusion criteria: Pulmonary complications; History of used bronchodilator medicines; fever; cough; sputum. Finally, in all three groups, the pulmonary complications, fever, cough, sputum production are evaluated in the first and second days after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052514359N2
Registration date: 2014-07-09, 1393/04/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-07-09, 1393/04/18
Registrant information
Name
Vally Imantalab
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
vimantalab@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three methods of preparing heavy smokers, quit smokers, non-quitters, under treatment with inhaler salbutamol_atrovent_ beclometazone with normal spirometry on respiratory complications after Coronary artery bypass grafting (CABG)
Public title
Effect of Salbutamol, Beclometazone nasal spray Atrovent Inhaler on pulmonary complications after Coronary artery bypass grafting (CABG)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 65-35 years old;Heavy smokers;Normal spirometry Exclusion criteria: Fever; Cough; Sputum
Age
From 35 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 225
Randomization (investigator's opinion)
N/A
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 Guilan university of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193893345
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
1920422823

Health conditions studied

1

Description of health condition studied
Pulmonary complications in heavy smokers
ICD-10 code
J95.9
ICD-10 code description
اختلال تنفسی

Primary outcomes

1

Description
cough
Timepoint
first and second days after surgery
Method of measurement
times per minute/question

2

Description
wheezing
Timepoint
first and second days after surgery
Method of measurement
Hearing lung

3

Description
rals
Timepoint
first and second days after surgery
Method of measurement
Hearing lung

4

Description
Time of mechanical ventilation
Timepoint
8 hours after surgery
Method of measurement
curve report

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1) smokers haven’t been treated and smoked before surgery
Category
Prevention

2

Description
Intervention2: smokers have been treated with salbutamol_atrovent _ beclometazon and smoked before surgery.
Category
Prevention

3

Description
Intervention 3: Smokers have quit smoking for 8 weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr.Heshmat Hospital
Full name of responsible person
Vali Imantalab
Street address
Next to the Management and Planning Organization, 15 Khordad street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
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 of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Vali Imantalab
Position
Anesthesiologist/ Assistant Professor
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1666 9066
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; vimantalb@yahoo.com
Web page address
www.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Vali Imantalab
Position
Anesthesiologist
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; vimantalab@yahoo.com
Web page address
www.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir

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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