Respiratory DepressionIPITrailNCT07451704
IPI-Guided Monitoring for Oxygen Desaturation in ERCP
A study testing IPI GROUP in people with Respiratory Depression and Oxygen Desaturation, run by Merve Gökçe at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates whether Integrated Pulmonary Index (IPI)-guided monitoring reduces oxygen desaturation and improves early detection of respiratory compromise during elective ERCP performed under standardized moderate sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Depression, Oxygen Desaturation, Hypoxemia
- What is being tested?
- IPI GROUP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2019to 5 Oct 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years,
- Scheduled for elective ERCP,
- ASA physical status I-IV
- Ability to provide written informed consent
Who cannot join
- Age <18 years
- ASA physical status ≥V
- Pregnancy or suspected pregnancy
- Known allergy to study sedative agents
- Obstructive or restrictive pulmonary disease
- Pre-procedural supplemental oxygen therapy or non-invasive ventilation
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- Predicted difficult airway
- Pre-procedural systolic blood pressure <90 mmHg
- Pre-procedural heart rate <60 beats/min
- Emergency ERCP
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludağ University Faculty of Medicine Hospital
Bursa, Görükle, 16100
About this study
Official title: IPI-Guided Monitoring Prevents Oxygen Desaturation During ERCP Under Moderate Sedation: A Randomized Controlled Trial
This randomized controlled trial evaluates whether Integrated Pulmonary Index (IPI)-guided monitoring reduces oxygen desaturation and improves early detection of respiratory compromise during elective ERCP performed under standardized moderate sedation.
Read the detailed description
Adults undergoing elective ERCP are randomized 1:1 to standard monitoring alone or standard monitoring plus visible IPI (SpO₂, respiratory rate, pulse rate, and EtCO₂). Sedation is standardized (midazolam, fentanyl, ketamine) with a target RASS of -3 and routine supplemental oxygen. Oxygen desaturation (>5% decrease in SpO₂ from baseline) during the procedure is the primary outcome. Secondary outcomes include hypoxemia (SpO₂ <90%), apnea, bradypnea, and the frequency of airway interventions (verbal-tactile stimulation, jaw-thrust, head-tilt).
- Conditions
- Respiratory Depression, Oxygen Desaturation, Hypoxemia
- Being tested
- IPI GROUP, CONTROL GROUP
- Keywords
- Integrated Pulmonary Index, ERCP, SEDATİON, AİRWAY MANGEMENT, CAPNOGRAPHY, RESPİRATORY
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI GROUPDiagnostic test
Real-time monitoring of SpO₂, respiratory rate, pulse rate, and end-tidal CO₂ using capnography with visible IPI values to guide airway interventions during ERCP under moderate sedation.
CONTROL GROUPDiagnostic test
Routine monitoring with ECG, non-invasive blood pressure, and pulse oximetry during ERCP under moderate sedation. IPI values are not displayed to the clinical team.
| Study group | Role | What they receive |
|---|---|---|
| IPI GROUP | Experimental | Standard monitoring plus visible IPI monitoring during ERCP under moderate sedation. Airway interventions are guided by predefined IPI thresholds. Receives: Diagnostic Test: IPI GROUP |
| CONTROL GROUP | Active comparator | Standard monitoring during ERCP under moderate sedation. IPI values are not displayed; interventions are based on standard clinical parameters. Receives: Diagnostic Test: CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Oxygen Desaturation
Occurrence of oxygen desaturation defined as a decrease in peripheral oxygen saturation (SpO₂) greater than 5% from baseline during the ERCP procedure.
Measured: During the ERCP procedure
Secondary outcomes (2)
Incidence of Hypoxemia
Occurrence of hypoxemia defined as SpO₂ < 90% during the ERCP procedure.
Measured: During the ERCP procedure
Incidence of Apnea
Occurrence of apnea detected by capnography during the procedure
Measured: During the ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start18 Oct 2019
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Gökçe
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Merve Gökçe, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451704
- Sponsor's protocol ID
- IPI-ERCP-2017
- Acronym
- IPITrail
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPI-Guided Monitoring Prevents Oxygen Desaturation During ERCP Under Moderate Sedation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07451704
- Acronym / sponsor ID
- IPITrail / IPI-ERCP-2017
- Conditions
- Respiratory Depression, Oxygen Desaturation, Hypoxemia
- Keywords
- Integrated Pulmonary Index, ERCP, SEDATİON, AİRWAY MANGEMENT, CAPNOGRAPHY, RESPİRATORY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Merve GökçeOther government
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 5 Mar 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 randomized controlled trial evaluates whether Integrated Pulmonary Index (IPI)-guided monitoring reduces oxygen desaturation and improves early detection of respiratory compromise during elective ERCP performed under standardized moderate sedation.
Detailed description
Adults undergoing elective ERCP are randomized 1:1 to standard monitoring alone or standard monitoring plus visible IPI (SpO₂, respiratory rate, pulse rate, and EtCO₂). Sedation is standardized (midazolam, fentanyl, ketamine) with a target RASS of -3 and routine supplemental oxygen. Oxygen desaturation (>5% decrease in SpO₂ from baseline) during the procedure is the primary outcome. Secondary outcomes include hypoxemia (SpO₂ <90%), apnea, bradypnea, and the frequency of airway interventions (verbal-tactile stimulation, jaw-thrust, head-tilt).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| IPI GROUP | Experimental | Diagnostic Test: IPI GROUPStandard monitoring plus visible IPI monitoring during ERCP under moderate sedation. Airway interventions are guided by predefined IPI thresholds. |
| CONTROL GROUP | Active comparator | Diagnostic Test: CONTROL GROUPStandard monitoring during ERCP under moderate sedation. IPI values are not displayed; interventions are based on standard clinical parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years,
- Scheduled for elective ERCP,
- ASA physical status I-IV
- Ability to provide written informed consent
Key exclusion criteria (10 listed)
- Age <18 years
- ASA physical status ≥V
- Pregnancy or suspected pregnancy
- Known allergy to study sedative agents
- Obstructive or restrictive pulmonary 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 |
|---|---|---|
| IPI GROUPReal-time monitoring of SpO₂, respiratory rate, pulse rate, and end-tidal CO₂ using capnography with visible IPI values to guide airway interventions during ERCP under moderate sedation. | Diagnostic test | IPI GROUP |
| CONTROL GROUPRoutine monitoring with ECG, non-invasive blood pressure, and pulse oximetry during ERCP under moderate sedation. IPI values are not displayed to the clinical team. | Diagnostic test | CONTROL GROUP |
Primary outcome
Incidence of Oxygen Desaturation
Time frame: During the ERCP procedure
Occurrence of oxygen desaturation defined as a decrease in peripheral oxygen saturation (SpO₂) greater than 5% from baseline during the ERCP procedure.
2 secondary outcomes
Incidence of Hypoxemia
Time frame: During the ERCP procedure
Incidence of Apnea
Time frame: During the ERCP procedure
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 5 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPI GROUP in people with Respiratory Depression and Oxygen Desaturation, run by Merve Gökçe 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 4 inclusion and 10 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 5 Mar 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 Oxygen Desaturation (time frame: During the ERCP procedure). 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 5 Mar 2026.