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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03025490
Enrollment
450
Registered
2017-01-19
Start date
2017-01-31
Completion date
Unknown
Last updated
2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Capnography, Sedation

Keywords

Capnography, Electrophysiology

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.

Interventions

Capnographic monitoring is used during the sedation.

Sponsors

Covidien Inc.
CollaboratorUNKNOWN
Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Rate of Sentinel Adverse Respiratory Events (AREs)One month

Secondary

MeasureTime frame
Mean time to detection of a Sentinel or Moderate AREOne month
Rate of Moderate Adverse Respiratory EventOne month
Rate of Minor Adverse Respiratory EventOne month
Rate of Minimal Adverse Respiratory EventOne month
Total rate of Adverse Respiratory EventOne month

Countries

Israel

Contacts

Primary ContactDavid Luria, MD
dluria@hadassah.org.il00 972 2 6778651
Backup ContactEmmanuel S Sirat, B.Med.Sc
emmanuel.sirat@mail.huji.ac.il00 972 50 3377276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026