Protocol summary

Summary
Study on 66 patients under mechanical ventilation in ICU of Imam Khomeini Hospital in Sari.Inclusion criteria : 65-18 years old patients with at least 72 hours and maximum a week intubation, absence of acute and chronic respiratory diseases such as: COPD, emphysema, atelectasis, asthma and bronchitis and chest trauma. Exclusion criteria: pulmonary edema؛severe bronchospasm ؛ tracheostomy؛ unstable vital signs؛ hypertension؛ hyperthyroid؛ pregnancy؛ corticosteroids؛ theophylline؛ expectorants؛ mucolytics medications, bronchodilators؛ allergy history of thyme؛ rosemary and mint. Data collection was done by demographic and medical data recording questionnaires and a checklists for information of airway condition and oxygen saturation. In Intervention group for 3 days, every 8 hours 4 drops of pure thyme essential oil with 10 cc distilled water is given with nebulizer. During the day before intervention and 3 days of intervention, respiratory secretions were collected and examined for weight, volume and concentration. At 8:00 and 10:00 in the morning, 6 area of patient's lung auscultation in the supine position, and the maximum and plateau pressure of airway and oxygen saturation are noted. The control group receives 10 cc distilled water with nebulizer every 8 hours for 3 days. During one day before intervention and 3 days of intervention, respiratory secretions were collected and examined in terms of weight, volume and concentration. At 8 and 10 am, 6 area of patient's lung auscultation in the supine position, and the maximum and plateau pressure of airway and oxygen saturation will be noted.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608117494N23
Registration date: 2017-07-24, 1396/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-24, 1396/05/02
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Science
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhaled Thyme on the airway condition and oxygen saturation in mechanically ventilated patients
Public title
The effect of Thyme on the airway condition and oxygen saturation in mechanically ventilated patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18-65 years old patients with at least 72 hours and maximum a week intubation; absence of acute and chronic respiratory diseases such as COPD, emphysema, atelectasis, asthma and bronchitis and chest trauma; Exclusion criteria: pulmonary edema; severe bronchospasm; tracheostomy; unstable vital signs; hypertension; hyperthyroidism; pregnancy; consumption of corticosteroids, theophylline, expectorants, mucolytics medications and bronchodilators؛ history of allergy to thyme, rosemary and mint.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
sari
Postal code
4816715793
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MAZUMS.REC.96-3097

Health conditions studied

1

Description of health condition studied
airway condition
ICD-10 code
R09.3
ICD-10 code description
Abnormal sputum

Primary outcomes

1

Description
secretion Concentration
Timepoint
1 day before intervention and 3 days of intervention
Method of measurement
Laboratory digital scale

2

Description
maximum and plateau airway pressure
Timepoint
1 day before intervention and 3 days of intervention
Method of measurement
Ventilator

3

Description
Ronka's breathing sound
Timepoint
1 day before intervention and 3 days of intervention, 8 and 10 Am
Method of measurement
stethoscope

Secondary outcomes

1

Description
oxygen saturation
Timepoint
1 day before intervention and 3 days of intervention
Method of measurement
oxygen saturation with pulse oximeter

Intervention groups

1

Description
Patient in the intervention group every 8 hour, for 30 minutes will receive an average of 10 cc distilled water with 4 drops of thyme essence، for 3 days.
Category
Prevention

2

Description
Patient in the control group will receive an average 10 cc distilled water for 3 days, every 8 hour, for 30 minutes
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam KHomeini hospital
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Street address
Emam khomeini hospital,Amir mazandarani Blv, Sari, Mazandaran, Iran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street, Moalem Square, Sari, Iran.
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran
City
sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
+98 11 3336 7551
Email
anna3043@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three way Joibar, highway Basij, Imam square, Sari, Mazandaran
City
sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
Email
anna3043@gmai.com; mbagheri@mazums.ac.ir
Web page address

Person responsible for updating data

Contact

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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