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Trial registered on ANZCTR


Registration number
ACTRN12607000232437
Ethics application status
Approved
Date submitted
30/04/2007
Date registered
2/05/2007
Date last updated
2/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Recovery of Ventilatory functions after open heart surgery:A prospective study.
Scientific title
The effect of low-level intensity laser on the recovery of Ventilatory functions on patients with Phrenic nerve injury after open heart surgery.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with Phrenic nerve injury complicating open heart surgery. 1763 0
Condition category
Condition code
Neurological 1855 1855 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: "Low-level intensity laser, cardiac rehabilitation" Laser with wave length ranged from 653-670nm& power of 5mW applied in contact over 6 points on the neck and chest for 5 minutes for each point. Each patient received 2 sessions/ week for 12 successive weeks.
cardiac rehabilitation involved Breathing exercise (3sets each set 3 times with one minute rest in between ) twice a day for 10 days post-operative, Passive range of motion exercises (10 times for each upper and lower limb joints) twice a day for two days post-operative, Active ankle pump (10 times) twice a day for two days post-operative, Active range of motion for lower and upper limbs (10 times for each joint) twice a day from day 2 to 10 post-operative, Calisthenics exercises to upper and lower limb (10 times for each joint) twice a day from day 3 to 10 post-operative, Walking with gradual increase in distance from day 3 post-operative to the end of the 12 weeks of the study.
Intervention code [1] 1729 0
Treatment: Devices
Comparator / control treatment
Control: "cardiac rehabilitation" same as for intervention group.
Control group
Active

Outcomes
Primary outcome [1] 2599 0
Ventilatory functions measured by spirometer test.
Timepoint [1] 2599 0
Pre-operative, Post-operative, 1st re-evaluation after 4 weeks of treatment, 2nd re-evaluation after 8 weeks and 3rd re-evaluation after 12 weeks of treatment.
Secondary outcome [1] 4458 0
Nil
Timepoint [1] 4458 0

Eligibility
Key inclusion criteria
Adult volunteer patient signed a consent form, Patient underwent open heart surgery in the duration form December 2003 to July 2005 and diagnosed as Phrenic nerve injured patient, Non smoker, patient performing primary cardiac surgery, Patient performed Coronar Artery Bypass Graft "CABG", valvular or adult congenital deficits closure surgery, patient able to understand verbally or by adminstration instructions needed to perform spirometer test.
Minimum age
21 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child patient, Patient with diabetes, neurological disorders or respiratory diseases, Patient performed operations other than those mentioned in subject inclusion criteria, Patient operated out of the mentioned duration, Patient re-doing cardiac operation, Patient with any learning barriers restrict spirometer test, Patient not intersted to be enrolled in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered Containers: Each of the particiated patient was given a code number written in small paper of the same size, color, and appearance. These papers were folded with the same way. These code numbers placed in a container.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using coin-tossing procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects participated were blinded in the study.
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2002 0
Self funded/Unfunded
Name [1] 2002 0
Dr. Salwa El-Sobkey
Address [1] 2002 0
Country [1] 2002 0
Primary sponsor type
Individual
Name
The principle investigator "Dr. Salwa El-Sobkey"
Address
Country
Secondary sponsor category [1] 1815 0
Individual
Name [1] 1815 0
Prof. Naguib Salem
Address [1] 1815 0
Country [1] 1815 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3711 0
Ethical Committee of college of Physical therapy- Cairo University
Ethics committee address [1] 3711 0
Giza
Ethics committee country [1] 3711 0
Egypt
Date submitted for ethics approval [1] 3711 0
Approval date [1] 3711 0
Ethics approval number [1] 3711 0
Ethics committee name [2] 3712 0
Ethical Committee of Department of Cardiothoracic Surgery- College of Medicine- Cairo University
Ethics committee address [2] 3712 0
Cairo
Ethics committee country [2] 3712 0
Egypt
Date submitted for ethics approval [2] 3712 0
Approval date [2] 3712 0
Ethics approval number [2] 3712 0

Summary
Brief summary
Phrenic nerve injury after open heart surgery is a well known complication. This complication interfer with the diaphrgmatic function and affect the vetilatory functions. This study aimed to assess the effect of low-level intensity laser on the recovery of Phrennic nerve and consequently the improvement in the vetilatory functions. The investigators hypothsis was null.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27832 0
Address 27832 0
Country 27832 0
Phone 27832 0
Fax 27832 0
Email 27832 0
Contact person for public queries
Name 10918 0
Dr. Salwa El-Sobkey
Address 10918 0
University of Sharjah
Sharjah
Country 10918 0
United Arab Emirates
Phone 10918 0
0097165057511
Fax 10918 0
0097165050802
Email 10918 0
elsobkey@sharjah.ac.ae
Contact person for scientific queries
Name 1846 0
Dr. Salwa El-Sobkey
Address 1846 0
University of Sharjah
Sharjah
Country 1846 0
United Arab Emirates
Phone 1846 0
0097165057511
Fax 1846 0
0097165050802
Email 1846 0
elsobkey@sharjah.ac.ae

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary