The aim of this study is a survey effect of sensory stimulation on respiratory weaning indices. In this study 30 patients with spontaneous breathing, that have not brain injury and neuromuscular disorders are selected. At first respiratory parameters such as respiratory rate, expiratory tidal volume, peak of inspiratory pressure, compliance and air way resistance are measured. Then, sensory stimulation included tactile stimulation, gustatory stimulation, auditory and positional stimulation used for 20-30 minutes. Immediately and one hour later the same respiratory parameters are measured.
General information
Acronym
Sensory Stimulation in Mechanical Ventilation
IRCT registration information
IRCT registration number:IRCT201409086481N5
Registration date:2014-09-15, 1393/06/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-15, 1393/06/24
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sensory Stimulation on Respiratory Weaning Indices of Patients from Mechanical Ventilation.
Public title
Effect of Sensory Stimulation on Weaning from Mechanical Ventilation.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Spontaneous breathing; Mechanical ventilation for 48 h or more than; Inform consent
Exclusion Criteria: Neuromuscular disorders; Long-term steroid therapy; Brain injury; End stage of cancer; Age over 70 years; Raised Intracranial pressure; Hip fracture; Artificial airway with tracheostomy
Age
From 14 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, 5th Km Damghan road, Semnan, Iran.
City
Semnan
Postal code
3513138111
Approval date
2014-08-30, 1393/06/08
Ethics committee reference number
93/490119
Health conditions studied
1
Description of health condition studied
Diseases of the respiratory system
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
Airway resistance
Timepoint
Before intervention, immediate after intervention, 1 hour later
Method of measurement
Display of mechanical ventilation
2
Description
Compliance
Timepoint
Before intervention, immediate after intervention, 1 hour later
Method of measurement
Display of mechanical ventilation
3
Description
Expiratory tidal volume
Timepoint
Before intervention, immediate after intervention, 1 hour later
Method of measurement
Display of mechanical ventilation
4
Description
Spontaneous breathing
Timepoint
Before intervention, immediate after intervention, 1 hour later
Method of measurement
Display of mechanical ventilation
5
Description
Blood Pressure
Timepoint
Before intervention, immediate after intervention, 1 hour later
Method of measurement
Display of monitoring
6
Description
Heart rate
Timepoint
Before intervention, immediate after intervention, 1 hour later
Method of measurement
Display of monitiring
7
Description
Peak of inspiratory pressure
Timepoint
Before intervention, immediate after intervention, 1 hour later
Method of measurement
Display of mechanical ventilation
Secondary outcomes
empty
Intervention groups
1
Description
Sensory stimulation before and after were used for one group of patients included:
1- Auditory stimulation
2- tactile stimulation
3- Gustatory stimulation
4- Positional stimulation
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Kashan
Full name of responsible person
Dr, seyed Mehdi Moosavi
Street address
Dr Beheshti Hospital, Ghotbe Ravandi Avenue
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidy-pour
Street address
Semnan University of Medical Sciences, Basij Avenue, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr, Mohsen Soleimani
Position
PhD of Nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, 5 th km Damghan road, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3365 4192
Fax
Email
Soli257@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr, Mohsen Soleimani
Position
PhD of Nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, 5th Km Damghan road, Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
3513138111
Phone
+98 23 3365 4197
Fax
Email
soli257@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr, Mohsen Soleimani
Position
PhD of Nursing
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, 5th Km Damghan road, Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3365 4192
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)