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

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03025490
• Other study ID #: EPCAPNO-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 21, 2016
• Last updated: January 16, 2017
• Start date: January 2017

Study information

• Verified date: November 2016
• Source: Hadassah Medical Organization
• Contact: David Luria, MD
• Phone: 00 972 2 6778651
• Email: dluria[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capnography
• Sedation

Intervention

Device:
• Capnographic monitoring
Capnographic monitoring is used during the sedation.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem District

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Covidien Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Sentinel Adverse Respiratory Events (AREs)		One month
Secondary	Mean time to detection of a Sentinel or Moderate ARE		One month
Secondary	Rate of Moderate Adverse Respiratory Event		One month
Secondary	Rate of Minor Adverse Respiratory Event		One month
Secondary	Rate of Minimal Adverse Respiratory Event		One month
Secondary	Total rate of Adverse Respiratory Event		One month