Procedural SedationNCT07749781
SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation
An observational study of Procedural Sedation and Gastrointestinal Endoscopy, run by Predictheon Medical, S.L. at 1 site in Spain.
Trial summary
The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation, Gastrointestinal Endoscopy
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jul 2026to Dec 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients scheduled for elective, non-emergent gastrointestinal endoscopic procedures requiring standard procedural sedation with propofol and remifentanil via TCI at the Endoscopy Unit of Hospital Clínic de Barcelona, Spain. Patients are identified during routine pre-procedural evaluation and enrolled consecutively after provision of written informed consent.
Who may be able to join
- Age ≥18 years
- ASA physical status I-III
- Scheduled for an elective, non-emergent gastrointestinal endoscopic procedure
- Procedural sedation planned with propofol and remifentanil administered via a target-controlled infusion (TCI) system
- Administration of sedative and analgesic drugs via a peripheral venous line
- Ability to understand the study information and provide written informed consent
Who cannot join
- Presence of medical conditions or use of medications that, in the investigator's judgment, could significantly interfere with the interpretation of physiological signals used as reference standards (e.g., severe autonomic dysfunction, severe movement disorders).
- Known severe neurologic, cardiovascular or respiratory disease that substantially alters baseline physiological monitoring or expected sedation response
- ASA physical status IV, V or VI
- Known or anticipated difficult airway requiring advanced airway management or interfering with standard respiratory monitoring
- Requirement for central venous access for drug administration
- Sedation performed outside the endoscopy unit (e.g., intensive care, emergency department)
- Inability to understand study information, provide consent or cooperate with clinical assessments due to language barrier or cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Julia Martínez Ocón, MD, 93 227 55 58, jocon@clinic.cat
Julia Martínez Ocón, MD
About this study
Official title: Prospective Observational Clinical Investigation to Evaluate the Clinical Performance and Safety of a Medical Device Software (SED Pack) During Standard Procedural Sedation
The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult patients at Hospital Clínic de Barcelona, Spain.
Procedural sedation consists in the administration of sedative and analgesic drugs to allow patients to undergo routine diagnostic or therapeutic procedures comfortably. Despite advances in monitoring technology, adverse events such as arterial hypotension, respiratory depression, or inadequate sedation remain frequent due to marked interindividual variability in drug response. Currently, clinicians rely on standard physiological monitoring that measures what is happening in real time but does not anticipate what is about to happen.
Read more
SED Pack is designed to address this gap by continuously processing physiological monitoring data and drug-infusion information to generate four real-time predictive indices (updated once per second): pSED (sedation depth), pNOC (likelihood of response to a noxious stimulus), pHYPO (likelihood of arterial hypotension), and pDEP (likelihood of respiratory depression).
In this clinical investigation, one hundred and twenty adult patients (≥18 years, ASA I-III) will be enrolled. Predictive performance is evaluated using the c-index for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC. The primary hypothesis is that each index achieves a discrimination performance ≥0.70 (lower bound of the 95% CI also ≥0.70). The software runs in fully blinded mode: its predictions are not visible to clinicians and do not influence patient management. No additional procedures beyond standard clinical care are introduced.
The study complies with MDR 2017/745 and ISO 14155, with AEMPS authorization and CEIm approval (reference: HCB/2026/0307).
Expected outcomes include confirmation that each SED Pack predictive index achieves clinically acceptable discrimination performance, supporting the clinical use of this investigational software as a tool to anticipate and prevent sedation-related complications.
Read the detailed description
Investigational device: SED Pack is a Medical Device Software (MDSW) that continuously processes physiological monitoring data and drug-infusion parameters to generate four real-time predictive indices (scale 0-100, updated once per second): pSED (probability of sedation depth from light sedation to general anesthesia), pNOC (probability of motor response to mild noxious stimuli), pHYPO (probability of clinically relevant arterial hypotension), and pDEP (probability of clinically relevant respiratory depression). The software incorporates a predefined individualization step that adjusts patient-specific parameters within a fixed model structure based on observed physiological signals. This process is deterministic and does not involve adaptive learning, model retraining, or self-modification. The algorithmic structure, logic, and parameters are fully locked throughout the investigation.
Study design: Prospective, observational, single-arm, single-center clinical investigation conducted under Article 62 of Regulation (EU) 2017/745 at Hospital Clínic de Barcelona, Spain. The investigation is non-interventional: no additional procedures beyond standard clinical care are introduced. The SED Pack software is installed on a dedicated PC connected via wired, unidirectional, read-only serial interfaces to standard clinical monitoring systems; the PC is not connected to any wireless or hospital network during the investigation. The software operates in fully blinded mode throughout: its predictions are not visible to the attending anesthesiologist, endoscopist, nursing staff, or investigators performing clinical reference assessments, and there is no break-glass mechanism for real-time visualization. All clinical decisions rely exclusively on standard-of-care CE-marked monitoring systems.
Patient enrollment: Participants are recruited among adult patients scheduled for elective gastrointestinal endoscopic procedures requiring procedural sedation at Hospital Clínic de Barcelona. Potentially eligible patients are identified during routine pre-procedural evaluation, provided with a patient information sheet and an informed consent form, and enrolled only after written informed consent is obtained. Participation is entirely voluntary and refusal or withdrawal does not affect standard medical care. Because the investigation does not deviate from routine clinical practice and introduces no additional procedures or risks, no study-specific patient training is required.
Performance evaluation and statistical analysis: The primary objective is to evaluate the predictive performance of the four SED Pack indices (pSED, pNOC, pHYPO, and pDEP) against predefined clinical and physiological reference standards, using the concordance statistic (c-index) for pSED, pHYPO, and pDEP, and the AUC-ROC for pNOC, complemented by sensitivity and specificity analyses at predefined operational thresholds. Secondary objectives include evaluation of predictive performance at short-term prediction horizons (+5 and +10 minutes), threshold-based AUC-ROC analyses against predefined binary clinical thresholds, and exploratory subgroup analyses by ASA physical status, age group, and sex. One pre-planned interim analysis will be conducted after enrollment of approximately 50% of the target sample for data quality assessment purposes only.
The anticipated outcome of this investigation is the confirmation that the SED Pack predictive indices achieve clinically acceptable discrimination performance against predefined reference standards, supporting the clinical performance claims of this investigational software. Ultimately, SED Pack has the potential to transform the monitoring paradigm during procedural sedation by enabling clinicians to anticipate adverse events before they occur, improving patient safety and supporting more individualized drug management.
- Conditions
- Procedural Sedation, Gastrointestinal Endoscopy
- Keywords
- Medical device software, Predictheon, Observational, Non-interventional, Predictive monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrimination Performance of pSED (Sedation Prediction Index)
Concordance statistic (c-index) comparing continuous pSED predictions against an ordinal clinical sedation scale (OAA/S- and Ramsay-derived; Level 1: light/no sedation; Level 2: moderate sedation; Level 3: deep sedation; Level 4: general anesthesia) assessed every 5 minutes by the investigator.
Measured: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)
Discrimination Performance of pNOC (Nociceptive Response Prediction Index)
AUC-ROC comparing continuous pNOC predictions against a binary reference standard: presence or absence of motor response (gag reflex or involuntary limb movement) during endoscope insertion or manipulation.
Measured: From the onset of procedural sedation to its completion, assessed at each endoscope insertion or manipulation event (estimated duration: 20 to 60 minutes per participant)
Discrimination Performance of pHYPO (Hypotension Prediction Index)
Concordance statistic (c-index) comparing continuous pHYPO predictions against non-invasive mean arterial pressure (MAP) measurements obtained at intervals not exceeding 5 minutes, using predefined hypotension thresholds (MAP <75, <65, and <55 mmHg).
Measured: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)
Discrimination Performance of pDEP (Respiratory Depression Prediction Index)
Concordance statistic (c-index) comparing continuous pDEP predictions against respiratory effort rate and tidal volume reference standard measurements, using predefined respiratory depression thresholds.
Measured: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)
Secondary outcomes (3)
Short-term Predictive Performance of pSED, pNOC, pHYPO, and pDEP at +5-Minute and +10-Minute Prediction Horizons
Concordance statistic (c-index) for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC, evaluated at +5-minute and +10-minute prediction horizons against the same reference standards used in the primary analysis. Performance thresholds and statistical methods are identical to those applied in the primary performance evaluation.
Measured: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)
Threshold-based Discrimination Performance of pSED, pHYPO, and pDEP Against Predefined Binary Clinical Thresholds
AUC-ROC for pSED, pHYPO, and pDEP predictions against binary classifications derived from predefined clinical thresholds (e.g., sedation level categories, hypotension thresholds, respiratory depression criteria)
Measured: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)
Exploratory Subgroup Analyses of Predictive Performance by ASA Physical Status, Age Group, and Sex
Discrimination metrics (c-index or AUC-ROC, as applicable) for each SED Pack predictive index compared across predefined patient subgroups: ASA physical status (I/II vs. III), age group (<65 vs. ≥65 years), and sex (male vs. female). These analyses are descriptive and exploratory; the study is not powered for inferential subgroup comparisons.
Measured: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start23 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Predictheon Medical, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749781
- Sponsor's protocol ID
- SED-PACK-1608-26
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Clinical Investigation to Evaluate the Clinical Performance and Safety of a Medical Device Software (SED Pack) During Standard Procedural Sedation
- ClinicalTrials.gov ID
- NCT07749781
- Acronym / sponsor ID
- SED-PACK-1608-26
- Conditions
- Procedural Sedation, Gastrointestinal Endoscopy
- Keywords
- Medical device software, Predictheon, Observational, Non-interventional, Predictive monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Predictheon Medical, S.L.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Aug 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.
The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult patients at Hospital Clínic de Barcelona, Spain.
Procedural sedation consists in the administration of sedative and analgesic drugs to allow patients to undergo routine diagnostic or therapeutic procedures comfortably. Despite advances in monitoring technology, adverse events such as arterial hypotension, respiratory depression, or inadequate sedation remain frequent due to marked interindividual variability in drug response. Currently, clinicians rely on standard physiological monitoring that measures what is happening in real time but does not anticipate what is about to happen.
SED Pack is designed to address this gap by continuously processing physiological monitoring data and drug-infusion information to generate four real-time predictive indices (updated once per second): pSED (sedation depth), pNOC (likelihood of response to a noxious stimulus), pHYPO (likelihood of arterial hypotension), and pDEP (likelihood of respiratory depression).
In this clinical investigation, one hundred and twenty adult patients (≥18 years, ASA I-III) will be enrolled. Predictive performance is evaluated using the c-index for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC. The primary hypothesis is that each index achieves a discrimination performance ≥0.70 (lower bound of the 95% CI also ≥0.70). The software runs in fully blinded mode: its predictions are not visible to clinicians and do not influence patient management. No additional procedures beyond standard clinical care are introduced.
The study complies with MDR 2017/745 and ISO 14155, with AEMPS authorization and CEIm approval (reference: HCB/2026/0307).
Expected outcomes include confirmation that each SED Pack predictive index achieves clinically acceptable discrimination performance, supporting the clinical use of this investigational software as a tool to anticipate and prevent sedation-related complications.
Detailed description
Investigational device: SED Pack is a Medical Device Software (MDSW) that continuously processes physiological monitoring data and drug-infusion parameters to generate four real-time predictive indices (scale 0-100, updated once per second): pSED (probability of sedation depth from light sedation to general anesthesia), pNOC (probability of motor response to mild noxious stimuli), pHYPO (probability of clinically relevant arterial hypotension), and pDEP (probability of clinically relevant respiratory depression). The software incorporates a predefined individualization step that adjusts patient-specific parameters within a fixed model structure based on observed physiological signals. This process is deterministic and does not involve adaptive learning, model retraining, or self-modification. The algorithmic structure, logic, and parameters are fully locked throughout the investigation.
Study design: Prospective, observational, single-arm, single-center clinical investigation conducted under Article 62 of Regulation (EU) 2017/745 at Hospital Clínic de Barcelona, Spain. The investigation is non-interventional: no additional procedures beyond standard clinical care are introduced. The SED Pack software is installed on a dedicated PC connected via wired, unidirectional, read-only serial interfaces to standard clinical monitoring systems; the PC is not connected to any wireless or hospital network during the investigation. The software operates in fully blinded mode throughout: its predictions are not visible to the attending anesthesiologist, endoscopist, nursing staff, or investigators performing clinical reference assessments, and there is no break-glass mechanism for real-time visualization. All clinical decisions rely exclusively on standard-of-care CE-marked monitoring systems.
Patient enrollment: Participants are recruited among adult patients scheduled for elective gastrointestinal endoscopic procedures requiring procedural sedation at Hospital Clínic de Barcelona. Potentially eligible patients are identified during routine pre-procedural evaluation, provided with a patient information sheet and an informed consent form, and enrolled only after written informed consent is obtained. Participation is entirely voluntary and refusal or withdrawal does not affect standard medical care. Because the investigation does not deviate from routine clinical practice and introduces no additional procedures or risks, no study-specific patient training is required.
Performance evaluation and statistical analysis: The primary objective is to evaluate the predictive performance of the four SED Pack indices (pSED, pNOC, pHYPO, and pDEP) against predefined clinical and physiological reference standards, using the concordance statistic (c-index) for pSED, pHYPO, and pDEP, and the AUC-ROC for pNOC, complemented by sensitivity and specificity analyses at predefined operational thresholds. Secondary objectives include evaluation of predictive performance at short-term prediction horizons (+5 and +10 minutes), threshold-based AUC-ROC analyses against predefined binary clinical thresholds, and exploratory subgroup analyses by ASA physical status, age group, and sex. One pre-planned interim analysis will be conducted after enrollment of approximately 50% of the target sample for data quality assessment purposes only.
The anticipated outcome of this investigation is the confirmation that the SED Pack predictive indices achieve clinically acceptable discrimination performance against predefined reference standards, supporting the clinical performance claims of this investigational software. Ultimately, SED Pack has the potential to transform the monitoring paradigm during procedural sedation by enabling clinicians to anticipate adverse events before they occur, improving patient safety and supporting more individualized drug management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective, non-emergent gastrointestinal endoscopic procedures requiring standard procedural sedation with propofol and remifentanil via TCI at the Endoscopy Unit of Hospital Clínic de Barcelona, Spain. Patients are identified during routine pre-procedural evaluation and enrolled consecutively after provision of written informed consent.
Key inclusion criteria (6 listed)
- Age ≥18 years
- ASA physical status I-III
- Scheduled for an elective, non-emergent gastrointestinal endoscopic procedure
- Procedural sedation planned with propofol and remifentanil administered via a target-controlled infusion (TCI) system
- Administration of sedative and analgesic drugs via a peripheral venous line
Key exclusion criteria (7 listed)
- Presence of medical conditions or use of medications that, in the investigator's judgment, could significantly interfere with the interpretation of physiological signals used as reference standards (e.g., severe autonomic dysfunction, severe movement disorders).
- Known severe neurologic, cardiovascular or respiratory disease that substantially alters baseline physiological monitoring or expected sedation response
- ASA physical status IV, V or VI
- Known or anticipated difficult airway requiring advanced airway management or interfering with standard respiratory monitoring
- Requirement for central venous access for drug administration
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
Discrimination Performance of pSED (Sedation Prediction Index)
Time frame: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)
Concordance statistic (c-index) comparing continuous pSED predictions against an ordinal clinical sedation scale (OAA/S- and Ramsay-derived; Level 1: light/no sedation; Level 2: moderate sedation; Level 3: deep sedation; Level 4: general anesthesia) assessed every 5 minutes by the investigator.
Discrimination Performance of pNOC (Nociceptive Response Prediction Index)
Time frame: From the onset of procedural sedation to its completion, assessed at each endoscope insertion or manipulation event (estimated duration: 20 to 60 minutes per participant)
AUC-ROC comparing continuous pNOC predictions against a binary reference standard: presence or absence of motor response (gag reflex or involuntary limb movement) during endoscope insertion or manipulation.
Discrimination Performance of pHYPO (Hypotension Prediction Index)
Time frame: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)
Concordance statistic (c-index) comparing continuous pHYPO predictions against non-invasive mean arterial pressure (MAP) measurements obtained at intervals not exceeding 5 minutes, using predefined hypotension thresholds (MAP <75, <65, and <55 mmHg).
Discrimination Performance of pDEP (Respiratory Depression Prediction Index)
Time frame: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)
Concordance statistic (c-index) comparing continuous pDEP predictions against respiratory effort rate and tidal volume reference standard measurements, using predefined respiratory depression thresholds.
3 secondary outcomes
Short-term Predictive Performance of pSED, pNOC, pHYPO, and pDEP at +5-Minute and +10-Minute Prediction Horizons
Time frame: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)
Threshold-based Discrimination Performance of pSED, pHYPO, and pDEP Against Predefined Binary Clinical Thresholds
Time frame: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)
Exploratory Subgroup Analyses of Predictive Performance by ASA Physical Status, Age Group, and Sex
Time frame: From the onset of procedural sedation to its completion (estimated duration: 20 to 60 minutes per participant)
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 6 Aug 2026.
- Predictheon webpageLink provided by the sponsor.
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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.
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 Procedural Sedation and Gastrointestinal Endoscopy, run by Predictheon Medical, S.L. at 1 site in Spain.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Aug 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 Spain. 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?
Contact Natalia Estrada Barreras, PhD (0034 610 32 11 21, nestrada@predictheon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discrimination Performance of pSED (Sedation Prediction Index) (time frame: From the onset of procedural sedation to its completion, assessed continuously during each sedation session (estimated duration: 20 to 60 minutes per participant)). The study lists 4 primary outcomes in all. 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 6 Aug 2026.