Heart Rate MonitoringNCT07719439
Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy
An observational study of Heart Rate Monitoring and Vagal Bradycardia, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study will assess whether perioperative short-term heart rate variability (HRV) indices and early inflammatory cytokine levels are associated with respiratory and cardiac adverse events in children undergoing elective adenoidectomy, tonsillectomy, or adenotonsillectomy under… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Heart Rate Monitoring, Vagal Bradycardia, Adenotonsillar Hypertrophy
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: 5-9 years, elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation * ASA physical status I-II; * Surgery planned under general anesthesia;
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Short-Term Heart Rate Variability and Early Inflammatory Cytokine Profile With Perioperative Respiratory and Cardiac Adverse Events in Pediatric Adenotonsillectomy: A Prospective Observational Cohort Study
This prospective observational cohort study will assess whether perioperative short-term heart rate variability (HRV) indices and early inflammatory cytokine levels are associated with respiratory and cardiac adverse events in children undergoing elective adenoidectomy, tonsillectomy, or adenotonsillectomy under general anesthesia. HRV will be recorded noninvasively from 30 minutes before surgery until discharge from the post-anesthesia care unit. Serum cytokines will be measured from 3 mL of residual blood obtained after induction of anesthesia. The study aims to identify perioperative physiologic markers associated with a lower or higher risk of adverse events, thereby supporting safer anesthetic planning.
Read the detailed description
Eligible children aged 5 to 9 years with ASA physical status I-II who are scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy will be enrolled consecutively after parental written informed consent. Standard clinical care will not be altered. HRV will be obtained using Holter/ECG monitoring and analyzed using time-domain (SDNN, RMSSD) and frequency-domain (LF, HF, LF/HF) measures. Standard intraoperative monitoring, Bispectral Index, and routine anesthetic management will be recorded. A residual 3 mL venous blood specimen collected at 5 minutes after intubation and before incision will be processed for IL-6, IL-8, IL-1, IL-1 beta, TNF-alpha, and IL-10 by ELISA. Postoperative emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale. Perioperative respiratory and cardiac adverse events will be prospectively documented until discharge from the PACU.
- Conditions
- Heart Rate Monitoring, Vagal Bradycardia, Adenotonsillar Hypertrophy, Tonsillitis; Hypertrophic, Adverse Cardiac Event, Respiratory Complication
- Medical subject headings
- Tonsillitis, Hypertrophy, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
HRV parameters' effect on perioperative cardiac events
Association between perioperative HRV parameters and perioperative respiratory/cardiac adverse events. HRV measures: SDNN, RMSSD, LF, HF, and LF/HF derived from Holter/ECG recordings. Adverse events include laryngospasm, bronchospasm, apnea/hypopnea, breath-holding, hypoxemia/desaturation, stridor, severe cough, and clinically relevant cardiac events. Time Frame: From 30 minutes before surgery until discharge from the PACU, up to 1 day.
Measured: 1 day. Until discharge from the PACU (same day)
Secondary outcomes (3)
Association between early serum cytokine concentrations (IL-6, IL-8, IL-1beta, TNF-alpha, IL-10) and perioperative respiratory/cardiac adverse events
Association between early serum cytokine concentrations (IL-6, IL-8, IL-1beta, TNF-alpha, IL-10) and perioperative respiratory/cardiac adverse events. Time Frame: Blood sampling at 5 minutes after intubation and before incision; adverse-event assessment until PACU discharge, up to 1 day.
Measured: 1 day
Association of HRV and PAED score after extubation
Postoperative emergence quality assessed by the Pediatric Anesthesia Emergence Delirium (PAED) score. Time Frame: First 30 minutes after extubation in the PACU.
Measured: 30 minute after extubation
Relationship of COLDS score and perioperative adverse events
Relationship of COLDS score, Bispectral Index values, demographic/operative variables, and anesthetic exposure with perioperative adverse events. Time Frame: Preoperative assessment through PACU discharge, up to 1 day.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sultan Baran Erkul, PhD, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719439
- Sponsor's protocol ID
- 2026/158
- Other IDs
- Duzce University (DÜBAP)
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Short-Term Heart Rate Variability and Early Inflammatory Cytokine Profile With Perioperative Respiratory and Cardiac Adverse Events in Pediatric Adenotonsillectomy: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07719439
- Acronym / sponsor ID
- 2026/158
- Conditions
- Heart Rate Monitoring, Vagal Bradycardia, Adenotonsillar Hypertrophy, Tonsillitis; Hypertrophic, Adverse Cardiac Event, Respiratory Complication
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational cohort study will assess whether perioperative short-term heart rate variability (HRV) indices and early inflammatory cytokine levels are associated with respiratory and cardiac adverse events in children undergoing elective adenoidectomy, tonsillectomy, or adenotonsillectomy under general anesthesia. HRV will be recorded noninvasively from 30 minutes before surgery until discharge from the post-anesthesia care unit. Serum cytokines will be measured from 3 mL of residual blood obtained after induction of anesthesia. The study aims to identify perioperative physiologic markers associated with a lower or higher risk of adverse events, thereby supporting safer anesthetic planning.
Detailed description
Eligible children aged 5 to 9 years with ASA physical status I-II who are scheduled for elective adenoidectomy, tonsillectomy, or adenotonsillectomy will be enrolled consecutively after parental written informed consent. Standard clinical care will not be altered. HRV will be obtained using Holter/ECG monitoring and analyzed using time-domain (SDNN, RMSSD) and frequency-domain (LF, HF, LF/HF) measures. Standard intraoperative monitoring, Bispectral Index, and routine anesthetic management will be recorded. A residual 3 mL venous blood specimen collected at 5 minutes after intubation and before incision will be processed for IL-6, IL-8, IL-1, IL-1 beta, TNF-alpha, and IL-10 by ELISA. Postoperative emergence delirium will be evaluated with the Pediatric Anesthesia Emergence Delirium scale. Perioperative respiratory and cardiac adverse events will be prospectively documented until discharge from the PACU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 5-9 years, elective adenoidectomy, tonsillectomy, or adenotonsillectomy operation * ASA physical status I-II; * Surgery planned under general anesthesia;
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HRV parameters' effect on perioperative cardiac events
Time frame: 1 day. Until discharge from the PACU (same day)
Association between perioperative HRV parameters and perioperative respiratory/cardiac adverse events. HRV measures: SDNN, RMSSD, LF, HF, and LF/HF derived from Holter/ECG recordings. Adverse events include laryngospasm, bronchospasm, apnea/hypopnea, breath-holding, hypoxemia/desaturation, stridor, severe cough, and clinically relevant cardiac events. Time Frame: From 30 minutes before surgery until discharge from the PACU, up to 1 day.
3 secondary outcomes
Association between early serum cytokine concentrations (IL-6, IL-8, IL-1beta, TNF-alpha, IL-10) and perioperative respiratory/cardiac adverse events
Time frame: 1 day
Association of HRV and PAED score after extubation
Time frame: 30 minute after extubation
Relationship of COLDS score and perioperative adverse events
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sultan Baran Erkul, PhD principal investigator
Duzce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Monitoring and Vagal Bradycardia, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRV parameters' effect on perioperative cardiac events (time frame: 1 day. Until discharge from the PACU (same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.