NCT03025490

Brief Summary

The study sets out to assess whether in the context of nurse administered procedural sedation in the electrophysiology suite, the routine use of capnography and Integrated Pulmonary Index results in lower incidence of severe adverse respiratory events.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Last Updated

January 19, 2017

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

November 21, 2016

Last Update Submit

January 16, 2017

Conditions

CapnographySedation

Keywords

CapnographyElectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Rate of Sentinel Adverse Respiratory Events (AREs)

    One month

Secondary Outcomes (5)

  • Mean time to detection of a Sentinel or Moderate ARE

    One month

  • Rate of Moderate Adverse Respiratory Event

    One month

  • Rate of Minor Adverse Respiratory Event

    One month

  • Rate of Minimal Adverse Respiratory Event

    One month

  • Total rate of Adverse Respiratory Event

    One month

Study Arms (2)

standard of Care

NO INTERVENTION

Patient undergoing sedation, treatment team does not have capnography data available.

Capnography

EXPERIMENTAL

Patient undergoing sedation, treatment team does have capnography data available.

Device: Capnographic monitoring

Interventions

Capnographic monitoringDEVICE

Capnographic monitoring is used during the sedation.

Also known as: Capnography, Integrated Pulmonary Index
Capnography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is 18 years of age or older
  • Patient is scheduled to undergo nurse administered procedural sedation in the electrophysiology laboratory.

You may not qualify if:

  • Patient is scheduled for anesthesiology based anesthesia.
  • Patient requires ventilator support at baseline (i.e. intubated patient, Bilevel Positive Airway Pressure or continuous positive airway pressure devices are in use)
  • Patient presents to electrophysiology laboratory with capnography monitoring in place.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem District, Israel

Location

MeSH Terms

Interventions

Capnography

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

David Luria, MD

CONTACT

00 972 2 6778651dluria@hadassah.org.il

Emmanuel S Sirat, B.Med.Sc

CONTACT

00 972 50 3377276emmanuel.sirat@mail.huji.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

February 1, 2019

Last Updated

January 19, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)