NCT05137587

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. In this study, we wanted to evaluate the value of IPI in cases of pediatric bronchoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

December 31, 2024

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

November 25, 2021

Last Update Submit

December 28, 2024

Conditions

Monitored Anesthesia CareRespiratory Monitoring

Outcome Measures

Primary Outcomes (1)

  • IPI-Ketamine

    Correlation of ketamine and IPI values

    Throughout the sedation procedure

Study Arms (2)

Group P

ACTIVE COMPARATOR

Patients sedated with propofol

Device: Integrated Pulmonary Index (IPI) monitoringDrug: propofol

Group K

ACTIVE COMPARATOR

Patients sedated with ketamine

Device: Integrated Pulmonary Index (IPI) monitoringDrug: ketamine

Interventions

Integrated Pulmonary Index (IPI) monitoringDEVICE

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.

Group KGroup P
propofolDRUG

propofol

Group P
ketamineDRUG

ketamine

Group K

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA 1-3 physical status
  • Elective upper or lower gastrointestinal tract endoscopy

You may not qualify if:

  • ASA physical status of 4 or more
  • Patients with any contraindication for off-site anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

Related Publications (4)

  • Taft A, Ronen M, Epps C, Waugh J, Wales R. A Novel Integrated Pulmonary Index (IPI) quantifies heart rate, etCO2, respiratory rate and SpO2%. ASA A1682, 22 Oct 2008.

    BACKGROUND

  • Berkenstadt H, Ben-Menachem E, Herman A, Dach R. An evaluation of the Integrated Pulmonary Index (IPI) for the detection of respiratory events in sedated patients undergoing colonoscopy. J Clin Monit Comput. 2012 Jun;26(3):177-81. doi: 10.1007/s10877-012-9357-x. Epub 2012 Mar 28.

    PMID: 22454276BACKGROUND

  • 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: 27671621BACKGROUND

  • Garah J, Adiv OE, Rosen I, Shaoul R. The value of Integrated Pulmonary Index (IPI) monitoring during endoscopies in children. J Clin Monit Comput. 2015 Dec;29(6):773-8. doi: 10.1007/s10877-015-9665-z. Epub 2015 Feb 11.

    PMID: 25666393BACKGROUND

MeSH Terms

Interventions

PropofolKetamine

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, Alicyclic

Study Officials

  • Ruslan Abdullayev

    Marmara University Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

November 25, 2021

First Posted

November 30, 2021

Study Start

September 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

December 31, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)