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A single score may spot breathing trouble before it's too late in sedated children

NCT ID NCT07733544

Symptom relief Sponsor: Ankara City Hospital Bilkent Source: ClinicalTrials.gov ↗

What the study statuses mean

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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.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a monitoring tool called the Integrated Pulmonary Index (IPI) can improve safety in children aged 2–18 who need deep sedation for procedures like lumbar puncture or bone marrow aspiration. IPI combines oxygen level, carbon dioxide, breathing rate, and heart rate into one number, aiming to catch breathing problems earlier than standard monitors. Researchers will compare how often breathing complications occur with and without IPI guidance.

What this could mean

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

Active substance
a sedation protocol with midazolam, fentanyl, and propofol, plus two monitoring devices (BIS and IPI)
What this could lead to
If IPI monitoring proves better at detecting breathing problems early, it could become a standard safety tool for sedating children during painful procedures.
What could go wrong
This is a small, single-center trial. IPI may not reduce complications enough to change practice, and the extra monitoring could add complexity without clear benefit.

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

80 people

The number who actually took part.

Started

Apr 2026

Finished

Jun 2026

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

The study population comprises pediatric patients aged 2 to 18 years who are scheduled for diagnostic or therapeutic hematologic interventions (such as bone marrow aspiration or lumbar puncture) at the Pediatric Hematology and Oncology Department of Ankara City Hospital. The cohort includes patients with an ASA Physical Status of I, II, or III who require deep sedation for these procedures.

Ages

2 to 18 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: * Patients undergoing hematologic interventions (Bone Marrow ---Aspiration/Lumbar Puncture). * ASA Physical Status I-III. * Age 2-18 years. Exclusion Criteria: * Parental refusal. * ASA score ≥ 4. * Allergy to Propofol or Fentanyl. * Advanced organ failure (Heart, Kidney, Liver, Lung). * Intracranial mass, epilepsy, or neuromuscular disease. * History of Malignant Hyperthermia

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As listed by the trial registrant

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

BIS Integrated pulmonary index Pediatric Pediatric hematology Sedation

Contacts and locations

Locations

  • Ankara Bilkent Şehir Hastanesi

    Ankara, Çankaya, 06800, Turkey (Türkiye)

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