Investigating autonomic dysfunction and hemodynamic stability during a specific surgical procedure for achalasia
Effect of Autonomic Dysfunction on Hemodynamic Instability During Per-oral Endoscopic Myotomy in Achalasia Patients: a Prospective Observational Study
This study is trying to see if patients with autonomic dysfunction have more blood pressure problems during a specific surgery for achalasia compared to those without this issue.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05772260 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between autonomic dysfunction and hemodynamic instability in patients undergoing per-oral endoscopic myotomy for achalasia. The study will assess autonomic function prior to surgery and monitor advanced hemodynamic parameters during the procedure using specialized equipment. The hypothesis is that patients with autonomic dysfunction will experience greater hemodynamic instability compared to those without. This research could provide insights into patient management during surgery for achalasia.
Who should consider this trial
Good fit: Ideal candidates are patients aged 19 and older scheduled for per-oral endoscopic myotomy at Gangnam Severance Hospital.
Not a fit: Patients who are hemodynamically unstable prior to surgery or unable to undergo the necessary autonomic function tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and outcomes of surgical procedures for achalasia patients by identifying those at higher risk for hemodynamic instability.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a potential link between autonomic dysfunction and surgical outcomes, suggesting that this area of investigation is relevant.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital 2. Patients aged ≥ 19 years Exclusion Criteria: 1. Patients who are hemodynamically unstable before surgery 2. Patients in whom preoperative heart rate variability (HRV) test cannot be conducted 3. Pregnant women of breastfeeding women 4. Patients unable to read the informed consent form
Where this trial is running
Seoul
- GangnamSeverance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: sunkyung Park
- Email: gsirb@yuhs.ac
- Phone: 82-2-2019-4601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.