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

H

Hadassah Medical Center

Status

Unknown

Conditions

Capnography
Sedation

Treatments

Device: Capnographic monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT03025490
EPCAPNO-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

450 participants in 2 patient groups

standard of Care
No Intervention group
Description:
Patient undergoing sedation, treatment team does not have capnography data available.
Capnography
Experimental group
Description:
Patient undergoing sedation, treatment team does have capnography data available.
Treatment:
Device: Capnographic monitoring

Trial contacts and locations

1

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Central trial contact

Emmanuel S Sirat, B.Med.Sc; David Luria, MD

Data sourced from clinicaltrials.gov

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