The Use of Capnography and Integrated Pulmonary Index in the Electrophysiology Laboratory

NCT ID: NCT03025490

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31

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.

Detailed Description

In the electrophysiology lab, the use of procedural sedation, often by nurses is considered routine and safe.Standard monitoring during these procedures includes continuous Oxygen Saturation (SpO2), Heart Rate and rhythm and interval Respiratory rate and blood pressure.

Capnography allows for continuous monitoring of exhaled carbon dioxide, it is an important tool during anesthesia, providing valuable information on the patient's respiratory status and is standard equipment in most operating rooms. Its use in procedural sedation has increased over the past years as the body of evidence supporting this practice has been growing.

It has been previously shown, use of capnography may allow for earlier detection of respiratory adverse events in various types of procedural sedation. The fall of oxygen saturation can occur very late during an adverse respiratory event, especially if supplemental oxygen is given. Today's procedural sedation in the electrophysiology catheterization lab are more complex, patients are of increasingly older age, have more comorbidities, procedures are lengthier and often require deeper sedation (i.e. during complex ablation procedures).

The use of capnography in the electrophysiology lab has not been addressed thoroughly in the literature. A recent multidisciplinary review of anesthesia in the electrophysiology lab states: "In the obstructive sleep apnea or non-obstructive sleep apnea patient, capnography should ideally be employed throughout the sedation period."…"Capnography appears to be underutilized in the electrophysiology lab, given its omission from electrophysiology literature documenting safety of sedation by non-anesthesiologists" We hypothesize that the routine use of capnography during nurse administered procedural sedations in the electrophysiology lab could aid in detection of early signs of adverse respiratory events, thus allowing early intervention and reduction of these events.

Conditions

Capnography; Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

standard of Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Capnography

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

Group Type: EXPERIMENTAL

Capnographic monitoring

Intervention Type: DEVICE

Capnographic monitoring is used during the sedation.

Interventions

Capnographic monitoring

Capnographic monitoring is used during the sedation.

Intervention Type: DEVICE

Other Intervention Names

Capnography; Integrated Pulmonary Index

Eligibility Criteria

Inclusion Criteria

1. Patient is 18 years of age or older

2. Patient is scheduled to undergo nurse administered procedural sedation in the electrophysiology laboratory.

Exclusion Criteria

1. Patient is scheduled for anesthesiology based anesthesia.

2. Patient requires ventilator support at baseline (i.e. intubated patient, Bilevel Positive Airway Pressure or continuous positive airway pressure devices are in use)

3. Patient presents to electrophysiology laboratory with capnography monitoring in place.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covidien Inc.

UNKNOWN

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Medical Organization

Jerusalem District, , Israel

Countries

Israel

Central Contacts

David Luria, MD

Role: CONTACT

dluria@hadassah.org.il

00 972 2 6778651

Emmanuel S Sirat, B.Med.Sc

Role: CONTACT

emmanuel.sirat@mail.huji.ac.il

00 972 50 3377276

Facility Contacts

Hadas Lemberg, PhD

Role: primary

lhadas@hadassah.org.il

00 972 2 6777572

Other Identifiers

EPCAPNO-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id