Acu Tens Versus Low Level Laser After Open Heart Surgeries
Acu Tens Versus Low Level Laser on Autonomic and Heamodynamic Stability After Open Heart Surgeries.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autonomic function reached lowest values 3-6 days after coronary artery by pass graft (CABG) and could take up to 60 days to return to pre-surgery values (pedro et al., 2005).
Alterations in pulse may provide a first indication that a patient is developing hemodynamic instability. While many factors may influence the pulse rate, including fever, exercise, medications, and thyroid hormone status, a high pulse rate is often a sign of high levels of endogenous catecholamines, blood loss or dehydration (Jonathan ,2009.) Hemodynamically unstable patients don't have enough pressure in the circulatory system to keep blood flowing reliably to all the various parts of the body where it needs to be at the same time.
Vagus nerve stimulation (VNS) can increase HRV and reduce sympathetic nerve outflow, which is desirable in conditions characterized by enhanced sympathetic nerve activity .
Application of Acu-TENS over acu-point PC6 facilitated a faster return of resting HR to preoperative levels, maintained BP during the acute postoperative period and enhanced a quicker return of rate pressure product (RPP), in patients after acute cardiac surgery .
Faster return of the raised resting HR to preoperative levels in Acu-TENS application was possibly due to induced vagal stimulation and/or inhibition of sympathetic neural activity through the acu-points PC6 .
Low level laser therapy (LLLT) is a non-invasive and safe method, to recover parasympathetic/sympathetic nervous system balance .
this study show the differences between the effect of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Kasr Ainy Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1- 60 patients from both sexes . 2- undergo cardiac surgery through a median sternotomy. 3- age will be ranged from 45-65 years old. 4-Body mass index from 25 to 29.9 kg/m25-
Exclusion Criteria:
- 1- Previous thoracic surgery. 2- Emergency or urgent cardiac surgery. 3- hypoxemia with partial pressure of oxygen in arterial blood <60 mmHg. 4- Renal insufficiency with serum creatinine ≤1.8 mg/dl after surgery. 5- Other medical conditions such as uncontrolled diabetes, and hypertension . 6- Patients who are unable to follow verbal instructions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: LLLT group
The LLLT group consist of (20) patients, who will receive the vagus nerve stimulation through LLLT from the first day postoperative until the seventh day, in addition to routine physiotherapy program
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low level laser therapy Probe laser device: (Laserklasse2M, EN60825-1, +A2:2002, W.L= 635-670nm, P<6mW, German):low level laser therapy It will be used to stimulate vagus nerve .
traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)
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Experimental: ACU tens group
The acu tense group consist of (20) patients, who will receive the acu tens on (pc6) point from the first day postoperative until the seventh day, in addition to routine physiotherapy program
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traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)
Acu-TENS device (Digital TENS, EAF20, JERF20BD0604, add manufacturing country): It will be used to stimulate vagus nerve throug h the acupoint PC6 .
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Active Comparator: control group
The control group consist of (20) patients, who will receive only routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)
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traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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heartrate variability.
Time Frame: heart rate variability parameters recorded for 24 hours 1st day post operative and at the last day before discharge from hospital for each group. before discharge from hospital .
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SDANN Standard deviation of the averages of RR intervals in all 50minute segments of a 24-hour recording.rMSSD
Square root of the mean of the squares of differences between adjacent RR intervals
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heart rate variability parameters recorded for 24 hours 1st day post operative and at the last day before discharge from hospital for each group. before discharge from hospital .
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Atrial fibrillation
Time Frame: AF recorded in 24 hours 1st day post operative and at the last day before discharge from hospital for each group.
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Atrial fibrillation occurs in 10% to 65% of patients after cardiac surgery, usually on the second or third postoperative day.
Postoperative atrial fibrillation is associated with increased morbidity and mortality and longer, more expensive hospital stay
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AF recorded in 24 hours 1st day post operative and at the last day before discharge from hospital for each group.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: zeinab helmy, professor, Cairo University
Publications and helpful links
General Publications
- Syuu Y, Matsubara H, Hosogi S, Suga H. Pressor effect of electroacupuncture on hemorrhagic hypotension. Am J Physiol Regul Integr Comp Physiol. 2003 Dec;285(6):R1446-52. doi: 10.1152/ajpregu.00243.2003. Epub 2003 Jul 31.
- Chandler HK, Kirsch R. Management of the Low Cardiac Output Syndrome Following Surgery for Congenital Heart Disease. Curr Cardiol Rev. 2016;12(2):107-11. doi: 10.2174/1573403x12666151119164647.
- Demirel S, Akkaya V, Oflaz H, Tukek T, Erk O. Heart rate variability after coronary artery bypass graft surgery: a prospective 3-year follow-up study. Ann Noninvasive Electrocardiol. 2002 Jul;7(3):247-50. doi: 10.1111/j.1542-474x.2002.tb00171.x.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p.T.REC/012/003894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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