The Value of Integrated Pulmonary Index Monitoring in Detecting Respiratory Events

Monitored Anesthesia Care Clinical Trial

Official title:

The Value of Integrated Pulmonary Index Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356819
• Other study ID #: GOKA/2020/16/6
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2022
• Source: Samsun Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Monitored Anesthesia Care

Intervention

Device:
• Smart Capnography™, Microstream®
patients monitored by capnograph

Locations

Country	Name	City	State
Turkey	Samsun Research and Education Hospital	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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 o — View Citation

Michael FA, Peveling-Oberhag J, Herrmann E, Zeuzem S, Bojunga J, Friedrich-Rust M. Evaluation of the Integrated Pulmonary Index® during non-anesthesiologist sedation for percutaneous endoscopic gastrostomy. J Clin Monit Comput. 2021 Oct;35(5):1085-1092. d — View Citation

Riphaus A, Wehrmann T, Kronshage T, Geist C, Pox CP, Heringlake S, Schmiegel W, Beitz A, Meining A, Müller M, von Delius S. Clinical value of the Integrated Pulmonary Index(®) during sedation for interventional upper GI-endoscopy: A randomized, prospectiv — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.