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Heartbeat clues may flag surgery risks in children

NCT ID NCT07719439

Knowledge-focused Sponsor: Duzce University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study looks at whether heart rate variability (small changes in heartbeat timing) and early signs of inflammation can help predict breathing or heart problems in children having their tonsils or adenoids removed. Researchers will monitor heart rhythms and measure immune markers in the blood of 76 children aged 5–9. The goal is to find simple signals that could help anesthesiologists plan safer care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If certain heart rate or inflammation patterns are linked to complications, doctors could better identify children at risk before surgery.
What could go wrong
This is a small observational study, not a treatment trial. It can only find associations, not prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

5-9 years, elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation * ASA physical status I-II; * Surgery planned under general anesthesia;

Ages

5 to 9 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 5-9 years; * elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation * ASA physical status I-II; * surgery planned under general anesthesia; * able to undergo standard endotracheal intubation and standard anesthetic protocol -; no dermatologic or cardiac barrier to preoperative Holter monitoring; * written informed consent provided by parent/legal guardian. Exclusion Criteria: * ASA physical status III or higher; congenital heart disease, arrhythmia, or cardiac conduction disorder; * known neurologic disease (e.g., epilepsy or cerebral palsy); * psychiatric diagnosis; * chronic inflammatory or immune-system disease; * acute infection within 2 weeks before surgery * regular steroid, immunosuppressive, or anti-inflammatory medication use; * endocrine disease such as uncontrolled thyroid disease; * preoperative hemodynamic instability; * major unexpected intraoperative complication or ICU requirement; * intraoperative atropine, lidocaine, beta-blocker, or epinephrine use; * history of prematurity or syndromic disease; * parent/legal guardian declines consent.

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Conditions

The condition(s) this trial relates to.

adenoid hypertrophy cardiovascular disorder Hypertrophy tonsillitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenotonsillar hypertrophy Adverse cardiac event Anesthesia Heart rate monitoring Respiratory complication Tonsillitis; hypertrophic Vagal bradycardia

Contacts and locations

Locations

  • Duzce University

    Düzce, 81620, Turkey (Türkiye)

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