Monitored Anesthesia CareNCT05356819
The Value of Integrated Pulmonary Index Monitoring in Detecting Respiratory Events
A study testing Smart Capnography™, Microstream® in people with Monitored Anesthesia Care, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Monitored Anesthesia Care
- What is being tested?
- Smart Capnography™, Microstream®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 31 Dec 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients monitored by capnograph
- ASA I-III
- Patients who underwent an elective endoscopic procedure
Who cannot join
- Patients who do not have capnograph monitoring or whose capnography records are missing
- Emergency endoscopic intervention (GIS bleeding, trauma, etc.)
- ASA IV-V
- Patients with pre-procedure SaO2 value below 90%, systolic blood pressure below 90 mmHg, heart rate below 50 beats/minute
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Research and Education Hospital
Samsun, 55090
About this study
Official title: The Value of Integrated Pulmonary Index Monitoring
Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements.The aim of the study is to determine whether the Integrated Pulmonary Index (IPI) detects changes in ventilation status early in patients undergoing gastrointestinal endoscopy under sedation, and to determine the risk factors affecting hypoxia and severe hypoxia.
Read the detailed description
A single-center and retrospective study was conducted in 154 patients who underwent upper and lower gastrointestinal system endoscopy in the endoscopy unit between October 2018 and December 2019. Patients who were monitored by capnograph in addition to routine monitoring (ECG, noninvasive blood pressure and pulse oximetry monitoring) during the procedure in the endoscopy unit were included in the study.
Patients were administered 2 mg midazolam as premedication for 5 minutes before the procedure and propofol 1-1.3 mg/kg bolus for sedation, followed by repeated doses (10-30 mg) according to the Ramsey sedation score. All patients were given 2 lt/min oxygen via nasal cannula during the procedure. In pulse oximetry, oxygen saturation longer than 15 seconds was defined as less than 92% hypoxia, and below 85% was defined as severe hypoxia.
IPI value was measured with Smart Capnography™, Microstream® Integrated Pulmonary Index device. According to the capnographic information obtained from the patients and preserved in the capnograph disc memory, the planned findings in the study are as follows:
- Number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds)
- Number of severe hypoxic events observed in patients (SaO2 value below 85%)
- Apnea episodes observed in patients (observation of a straight line longer than 15 seconds on the capnograph, absence of respiratory activity)
- Time from apnea to development of hypoxia and severe hypoxia in patients who develop hypoxia and severe hypoxia following apnea
- Time between IPI=1, IPI<7, EtCO2=0 and hypoxia and severe hypoxia.
- Conditions
- Monitored Anesthesia Care
- Being tested
- Smart Capnography™, Microstream®
- Keywords
- Integrated Pulmonary Index (IPI) monitoring, capnograph, endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Capnography™, Microstream®Device
patients monitored by capnograph
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy | Other | Integrated Pulmonary Index (IPI) monitor will be applied to the patients, to provide numerical data obtained from the measurements of end-tidal carbon dioxide, respiratory rate, oxygen saturation measured by pulse oximetry (SpO2), and pulse rate.
Patients were administered 2 mg midazolam as premedication for 5 minutes before the procedure and propofol 1-1.3 mg/kg bolus for sedation, followed by repeated doses (10-30 mg) according to the Ramsey sedation score. All patients were given 2 lt/min oxygen via nasal cannula during the procedure. Receives: Device: Smart Capnography™, Microstream® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated pulmoner index and puls oxymetry
The number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds) and number of severe hypoxic events observed in patients (SaO2 value below 85%)
Measured: From the time between first sedative medication administration to the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Oct 2018
- Primary completion1 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Monitored Anesthesia CareStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale Kefeli Celik, Samsun Education and Research Hospital
- Investigators
- HALE KEFELİ ÇELİK, MD, Study director, Samsun Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356819
- Sponsor's protocol ID
- GOKA/2020/16/6
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study
Publications
Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
PubMed 21072716Wehrmann T, Riphaus A. Sedation with propofol for interventional endoscopic procedures: a risk factor analysis. Scand J Gastroenterol. 2008 Mar;43(3):368-74. doi: 10.1080/00365520701679181.
PubMed 18938664Riphaus 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 27671621Michael FA, Peveling-Oberhag J, Herrmann E, Zeuzem S, Bojunga J, Friedrich-Rust M. Evaluation of the Integrated Pulmonary Index(R) during non-anesthesiologist sedation for percutaneous endoscopic gastrostomy. J Clin Monit Comput. 2021 Oct;35(5):1085-1092. doi: 10.1007/s10877-020-00563-2. Epub 2020 Jul 30.
PubMed 32734356
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Integrated Pulmonary Index Monitoring
- ClinicalTrials.gov ID
- NCT05356819
- Acronym / sponsor ID
- GOKA/2020/16/6
- Conditions
- Monitored Anesthesia Care
- Keywords
- Integrated Pulmonary Index (IPI) monitoring, capnograph, endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 May 2022 (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.
Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements.The aim of the study is to determine whether the Integrated Pulmonary Index (IPI) detects changes in ventilation status early in patients undergoing gastrointestinal endoscopy under sedation, and to determine the risk factors affecting hypoxia and severe hypoxia.
Detailed description
A single-center and retrospective study was conducted in 154 patients who underwent upper and lower gastrointestinal system endoscopy in the endoscopy unit between October 2018 and December 2019. Patients who were monitored by capnograph in addition to routine monitoring (ECG, noninvasive blood pressure and pulse oximetry monitoring) during the procedure in the endoscopy unit were included in the study.
Patients were administered 2 mg midazolam as premedication for 5 minutes before the procedure and propofol 1-1.3 mg/kg bolus for sedation, followed by repeated doses (10-30 mg) according to the Ramsey sedation score. All patients were given 2 lt/min oxygen via nasal cannula during the procedure. In pulse oximetry, oxygen saturation longer than 15 seconds was defined as less than 92% hypoxia, and below 85% was defined as severe hypoxia.
IPI value was measured with Smart Capnography™, Microstream® Integrated Pulmonary Index device. According to the capnographic information obtained from the patients and preserved in the capnograph disc memory, the planned findings in the study are as follows:
- Number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds)
- Number of severe hypoxic events observed in patients (SaO2 value below 85%)
- Apnea episodes observed in patients (observation of a straight line longer than 15 seconds on the capnograph, absence of respiratory activity)
- Time from apnea to development of hypoxia and severe hypoxia in patients who develop hypoxia and severe hypoxia following apnea
- Time between IPI=1, IPI<7, EtCO2=0 and hypoxia and severe hypoxia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy | Other | Device: Smart Capnography™, Microstream®Integrated Pulmonary Index (IPI) monitor will be applied to the patients, to provide numerical data obtained from the measurements of end-tidal carbon dioxide, respiratory rate, oxygen saturation measured by pulse oximetry (SpO2), and pulse rate. Patients were administered 2 mg midazolam as premedication for 5 minutes before the procedure and propofol 1-1.3 mg/kg bolus for sedation, followed by repeated doses (10-30 mg) according to the Ramsey sedation score. All patients were given 2 lt/min oxygen via nasal cannula during the procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients monitored by capnograph
- ASA I-III
- Patients who underwent an elective endoscopic procedure
Key exclusion criteria (4 listed)
- Patients who do not have capnograph monitoring or whose capnography records are missing
- Emergency endoscopic intervention (GIS bleeding, trauma, etc.)
- ASA IV-V
- Patients with pre-procedure SaO2 value below 90%, systolic blood pressure below 90 mmHg, heart rate below 50 beats/minute
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 |
|---|---|---|
| Smart Capnography™, Microstream®patients monitored by capnograph | Device | Endoscopy |
Primary outcome
Integrated pulmoner index and puls oxymetry
Time frame: From the time between first sedative medication administration to the end of the procedure.
The number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds) and number of severe hypoxic events observed in patients (SaO2 value below 85%)
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 2 May 2022.
- Results publication: PubMed 21072716Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
- Results publication: PubMed 18938664Wehrmann T, Riphaus A. Sedation with propofol for interventional endoscopic procedures: a risk factor analysis. Scand J Gastroenterol. 2008 Mar;43(3):368-74. doi: 10.1080/00365520701679181.
- 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.
- Results publication: PubMed 32734356Michael FA, Peveling-Oberhag J, Herrmann E, Zeuzem S, Bojunga J, Friedrich-Rust M. Evaluation of the Integrated Pulmonary Index(R) during non-anesthesiologist sedation for percutaneous endoscopic gastrostomy. J Clin Monit Comput. 2021 Oct;35(5):1085-1092. doi: 10.1007/s10877-020-00563-2. Epub 2020 Jul 30.
- Individual participant dataSharing planned: No. Our data and statistical analysis of each investigated all parameter and data are available after the publication of the clinical study
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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.
HALE KEFELİ ÇELİK, MD study director
Samsun Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Capnography™, Microstream® in people with Monitored Anesthesia Care, run by Samsun Education and Research Hospital 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 4 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 2 May 2022. 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?
Integrated pulmoner index and puls oxymetry (time frame: From the time between first sedative medication administration to the end of the procedure.). 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 NCT05356819, which also lists 4 linked publications.
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 2 May 2022.