The Value of Integrated Pulmonary Index Monitoring in Detecting Respiratory Events

NCT05356819 | Completed

• 1 other identifier: GOKA/2020/16/6
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Monitored Anesthesia Care

Keywords

Integrated Pulmonary Index (IPI) monitoring; capnograph; endoscopy

Outcome Measures

Primary Outcomes (1)

• 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%)

  From the time between first sedative medication administration to the end of the procedure.

Study Arms (1)

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.

Device: Smart Capnography™, Microstream®

Interventions

Smart Capnography™, Microstream® DEVICE

patients monitored by capnograph

Endoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Research and Education Hospital

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 21072716 RESULT

• 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.

  PMID: 18938664 RESULT

• 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.

  PMID: 27671621 RESULT

• 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.

  PMID: 32734356 RESULT

Study Officials

• HALE KEFELİ ÇELİK, MD

  Samsun Research and Education Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 2, 2022
• Study Start: October 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 31, 2019
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)