Clinical trial NCT03025490: The Use of Capnography and Integrated Pulmonary Index in the Electrophysiology Laboratory
Official title: The Use of Capnography and Integrated Pulmonary Index in the Electrophysiology Laboratory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Capnography
Sedation
Keywords: Capnography
Electrophysiology
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Covidien Inc.
First posted: 2017-01-19
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Rate of Sentinel Adverse Respiratory Events (AREs)
timeFrame: One month
Secondary outcomes:
measure: Mean time to detection of a Sentinel or Moderate ARE
timeFrame: One month
measure: Rate of Moderate Adverse Respiratory Event
timeFrame: One month
measure: Rate of Minor Adverse Respiratory Event
timeFrame: One month
measure: Rate of Minimal Adverse Respiratory Event
timeFrame: One month
measure: Total rate of Adverse Respiratory Event
timeFrame: One month
Other outcomes:
Locations:
city: Jerusalem District
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: