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

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.

Study Overview

• Status: Unknown
• Conditions: Sedation; Capnography
• Intervention / Treatment: Device: Capnographic monitoring

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem District, Israel
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard of Care; Patient undergoing sedation, treatment team does not have capnography data available.
Experimental: Capnography; Patient undergoing sedation, treatment team does have capnography data available.	Device: Capnographic monitoring; Capnographic monitoring is used during the sedation.; Other Names: Capnography; Integrated Pulmonary Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Sentinel Adverse Respiratory Events (AREs)	One month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Covidien Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: January 16, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Estimate): January 19, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Electrophysiology; Capnography
• Other Study ID Numbers: EPCAPNO-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO