Clinical trial NCT05356819: The Value of Integrated Pulmonary Index Monitoring in Detecting Respiratory Events
Official title: The Value of Integrated Pulmonary Index Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Monitored Anesthesia Care
Keywords: Integrated Pulmonary Index (IPI) monitoring
capnograph
endoscopy
Lead sponsor: Samsun Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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). 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:

1. Number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds)
2. Number of severe hypoxic events observed in patients (SaO2 value below 85%)
3. Apnea episodes observed in patients (observation of a straight line longer than 15 seconds on the capnograph, absence of respiratory activity)
4. Time from apnea to development of hypoxia and severe hypoxia in patients who develop hypoxia and severe hypoxia following apnea
5. Time between IPI=1, IPI\<7, EtCO2=0 and hypoxia and severe hypoxia.

Eligibility criteria: Inclusion Criteria:

* Patients monitored by capnograph
* ASA I-III
* Patients who underwent an elective endoscopic procedure

Exclusion Criteria:

* 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

Primary outcomes:
measure: Integrated pulmoner index and puls oxymetry
timeFrame: From the time between first sedative medication administration to the end of the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Research and Education Hospital
Study officials:
affiliation: Samsun Research and Education Hospital
name: HALE KEFELİ ÇELİK, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Wehrmann 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.
citation: 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.
citation: Michael 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.