Skip to main content
OpenTrials
Completed

NCT Number: NCT06637085

Acu Tens Versus Low Level Laser After Open Heart Surgeries

Increase in heart rate (HR) is a normal sympathetic response to body trauma and a common consequence of major surgical procedures,A high resting HR is associated with increased myocardial work that may be detrimental to patients with a marginal myocardial oxygen supply,the aim of this study is To compare between the effects of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Ainy Hospital

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LLLT

Device

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

Other

traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)

ACU TENSE

Device

Acu-TENS device (Digital TENS, EAF20, JERF20BD0604, add manufacturing country): It will be used to stimulate vagus nerve throug h the acupoint PC6 .

Primary outcomes

  1. 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 .

    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

Secondary outcomes

  1. 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.

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Acu Tens Versus Low Level Laser on Autonomic and Heamodynamic Stability After Open Heart Surgeries.

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.