SedationNCT07733544
Sedation Safety Assessment Using IPI Monitoring in Pediatric Hematologic Procedures
An observational study of Sedation and Pediatric, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Pediatric hematologic procedures such as lumbar puncture and bone marrow aspiration often require deep sedation due to pain and the need for immobility. Sedative and opioid combinations increase the risk of respiratory depression. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Sedation, Pediatric, Integrated Pulmonary Index
- What is being tested?
- Deep Sedation with IPI and BIS Monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 9 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- Patients undergoing hematologic interventions (Bone Marrow ---Aspiration/Lumbar Puncture).
- ASA Physical Status I-III.
- Age 2-18 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent Şehir Hastanesi
Ankara, Çankaya, 06800
About this study
Official title: Evaluation of Sedation Safety Using Integrated Pulmonary Index (IPI) Monitoring During Pediatric Hematologic Procedures Performed Under BIS Monitoring
Pediatric hematologic procedures such as lumbar puncture and bone marrow aspiration often require deep sedation due to pain and the need for immobility. Sedative and opioid combinations increase the risk of respiratory depression. Integrated Pulmonary Index (IPI) combines SpO₂, EtCO₂, respiratory rate, and heart rate into a single score and may allow earlier detection of respiratory compromise. This study aims to evaluate the safety and effectiveness of IPI monitoring in pediatric patients undergoing hematologic procedures under sedation with BIS monitoring.
- Conditions
- Sedation, Pediatric, Integrated Pulmonary Index, BIS, Pediatric Hematology
- Being tested
- Deep Sedation with IPI and BIS Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Sedation with IPI and BIS MonitoringProcedure or surgery
Standard sedation protocol including Midazolam (0.03 mg/kg), Fentanyl (1 mcg/kg), and Propofol (1-2 mg/kg). Monitoring includes standard ASA monitors plus Bispectral Index (BIS) and Integrated Pulmonary Index (IPI).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 :Ages 2-5 | Patients aged between 2 and 5 years undergoing hematologic procedures under sedation. Receives: Procedure: Deep Sedation with IPI and BIS Monitoring | |
| Group 2 : Ages 6-11 | Patients aged between 6 and 11 years undergoing hematologic procedures under sedation. Receives: Procedure: Deep Sedation with IPI and BIS Monitoring | |
| Group 3: Ages 12-18 | Patients aged between 12 and 18 years undergoing hematologic procedures under sedation. Receives: Procedure: Deep Sedation with IPI and BIS Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Respiratory Adverse Events (Hypoxia and Apnea)
Evaluation of respiratory safety using standard monitoring versus Integrated Pulmonary Index (IPI). Apnea is defined as cessation of CO2 exhalation for 15 seconds. Hypoxia is defined as SpO2 ≤ 92% or an IPI score drop to ≤ 6. Interventions required (e.g., jaw thrust, oxygen increase) will be recorded.
Measured: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Incidence of Respiratory Adverse Events (Apnea/Hypoxia)
Apnea is defined as cessation of CO2 exhalation for 15 seconds. Hypoxia is defined as SpO2 ≤ 92% or IPI ≤ 6
Measured: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Secondary outcomes (5)
Time to Recovery
Time required for the patient to reach a Modified Aldrete Score of ≥8 (assessing respiration, O2 saturation, consciousness, circulation, and activity) ready for discharge from the recovery room.
Measured: Immediately after the procedure until achievement of a Modified Aldrete Score >=8
Depth of Anesthesia
Assessment of anesthetic depth using Bispectral Index (BIS) monitoring to maintain adequate hypnosis during the procedure.
Measured: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Anesthetic Drug Consumption
Total cumulative dose of Propofol (mg/kg) Total cumulative dose of Fentanyl (mcg/kg)
Measured: During the procedure, up to 30 minutes after initiation of the procedure
Hemodynamic and Respiratory Parameters
Intraoperative monitoring included:
Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP) Mean Arterial Pressure (MAP) Heart Rate (HR) Peripheral Oxygen Saturation (SpO₂) Respiratory Rate (RR) End-tidal Carbon Dioxide (EtCO₂)
Measured: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Adverse Events
Postoperative Nausea and Vomiting (PONV) Agitation Bronchospasm Laryngospasm
Measured: Periprocedurally, from induction of sedation until transfer to the hospital ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Apr 2026
- Primary completion12 May 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vildan Ergen, Ankara City Hospital Bilkent
- Investigators
- VILDAN ERGEN, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733544
- Sponsor's protocol ID
- TABED 1-26-2051
- Status last verified
- Jul 2026
- First submitted
- 16 Feb 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riphaus A, Wehrmann T, Kronshage T, Geist C, Pox CP, Heringlake S, Schmiegel W, Beitz A, Meining A, Muller M, von Delius S. Clinical value of the Integrated Pulmonary Index(R) during sedation for interventional upper GI-endoscopy: A randomized, prospective tri-center study. Dig Liver Dis. 2017 Jan;49(1):45-49. doi: 10.1016/j.dld.2016.08.124. Epub 2016 Sep 1.
PubMed 27671621
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sedation Safety Using Integrated Pulmonary Index (IPI) Monitoring During Pediatric Hematologic Procedures Performed Under BIS Monitoring
- ClinicalTrials.gov ID
- NCT07733544
- Acronym / sponsor ID
- TABED 1-26-2051
- Conditions
- Sedation, Pediatric, Integrated Pulmonary Index, BIS, Pediatric Hematology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 29 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.
Pediatric hematologic procedures such as lumbar puncture and bone marrow aspiration often require deep sedation due to pain and the need for immobility. Sedative and opioid combinations increase the risk of respiratory depression. Integrated Pulmonary Index (IPI) combines SpO₂, EtCO₂, respiratory rate, and heart rate into a single score and may allow earlier detection of respiratory compromise. This study aims to evaluate the safety and effectiveness of IPI monitoring in pediatric patients undergoing hematologic procedures under sedation with BIS monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 :Ages 2-5 | – | Procedure: Deep Sedation with IPI and BIS MonitoringPatients aged between 2 and 5 years undergoing hematologic procedures under sedation. |
| Group 2 : Ages 6-11 | – | Procedure: Deep Sedation with IPI and BIS MonitoringPatients aged between 6 and 11 years undergoing hematologic procedures under sedation. |
| Group 3: Ages 12-18 | – | Procedure: Deep Sedation with IPI and BIS MonitoringPatients aged between 12 and 18 years undergoing hematologic procedures under sedation. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Patients undergoing hematologic interventions (Bone Marrow ---Aspiration/Lumbar Puncture).
- ASA Physical Status I-III.
- Age 2-18 years.
Key exclusion criteria (6 listed)
- Parental refusal.
- ASA score ≥ 4.
- Allergy to Propofol or Fentanyl.
- Advanced organ failure (Heart, Kidney, Liver, Lung).
- Intracranial mass, epilepsy, or neuromuscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Sedation with IPI and BIS MonitoringStandard sedation protocol including Midazolam (0.03 mg/kg), Fentanyl (1 mcg/kg), and Propofol (1-2 mg/kg). Monitoring includes standard ASA monitors plus Bispectral Index (BIS) and Integrated Pulmonary Index (IPI). | Procedure or surgery | Group 1 :Ages 2-5, Group 2 : Ages 6-11, Group 3: Ages 12-18 |
Primary outcome
Incidence of Respiratory Adverse Events (Hypoxia and Apnea)
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Evaluation of respiratory safety using standard monitoring versus Integrated Pulmonary Index (IPI). Apnea is defined as cessation of CO2 exhalation for 15 seconds. Hypoxia is defined as SpO2 ≤ 92% or an IPI score drop to ≤ 6. Interventions required (e.g., jaw thrust, oxygen increase) will be recorded.
Incidence of Respiratory Adverse Events (Apnea/Hypoxia)
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Apnea is defined as cessation of CO2 exhalation for 15 seconds. Hypoxia is defined as SpO2 ≤ 92% or IPI ≤ 6
5 secondary outcomes
Time to Recovery
Time frame: Immediately after the procedure until achievement of a Modified Aldrete Score >=8
Depth of Anesthesia
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Anesthetic Drug Consumption
Time frame: During the procedure, up to 30 minutes after initiation of the procedure
Hemodynamic and Respiratory Parameters
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Adverse Events
Time frame: Periprocedurally, from induction of sedation until transfer to the hospital ward
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Results publication: PubMed 27671621Riphaus A, Wehrmann T, Kronshage T, Geist C, Pox CP, Heringlake S, Schmiegel W, Beitz A, Meining A, Muller M, von Delius S. Clinical value of the Integrated Pulmonary Index(R) during sedation for interventional upper GI-endoscopy: A randomized, prospective tri-center study. Dig Liver Dis. 2017 Jan;49(1):45-49. doi: 10.1016/j.dld.2016.08.124. Epub 2016 Sep 1.
- 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.
VILDAN ERGEN, MD principal investigator
Ankara City Hospital Bilkent
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 Sedation and Pediatric, run by Ankara City Hospital Bilkent 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 29 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Respiratory Adverse Events (Hypoxia and Apnea) (time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07733544, which also lists 1 linked publication.
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 29 Jul 2026.