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Clinical Trials/NCT01733446
NCT01733446CompletedNot Applicable

A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration With Respiratory Inductance Plethysmography (RIP) During High Frequency Jet Ventilation (HFJV) Under General Anesthesia

University of Pennsylvania1 site in 1 country50 target enrollmentStarted: September 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
spontaneous breathing

Study Overview

Brief Summary

The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event.

The present study aims to further clarify the physiology of recovery of breathing with the addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of two different recovery paradigms.

Detailed Description

The present study will use non-invasive respiratory inductance plethysmography(RIP) and transcutaneous carbon dioxide measurement to compare recovery of respiration under constant Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet ventilation HFJV (study method) with recovery of respiration during rising and apnea (current standard).

The investigators hypothesize that the prolonged abdominal expiration that we observed during recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2) levels.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or Female patients ages > 18 to < 80
  • •Scheduled for procedures under general anesthesia with jet ventilation
  • •Sign informed consent
  • •Candidate for total intravenous anesthesia with propofol and remifentanil (which is standard protocol in this type of population)

Exclusion Criteria

  • •Absence of informed consent
  • •No planned use intra-operative use of jet ventilation
  • •Known difficulties with jet ventilation during prior surgical procedures
  • •Emergency surgery
  • •Baseline (oxygen saturation)SpO2 <92% on room air
  • •Pregnant or lactating females
  • •Skin damage, rash or significant lesions in the areas covered by the RIP bands or transcutaneous CO2 sensor.

Arms & Interventions

Standard anesthesia regimen

No Intervention

Positive pressure ventilation will be stopped at the same time infusions of anesthetic agents and spontaneous ventilation employed until emergence from anesthesia is observed. (This is standard protocol for everyday anesthesia management of this population.)

Continuation of High Frequency Jet Ventilation ( HFJV)

Experimental

In Group B after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.

Intervention: Continuation of High Frequency Jet Ventilation (HFJV) (Other)

Outcomes

Primary Outcomes

spontaneous breathing

Time Frame: Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath

The primary variable will be first breath as detected by Respiratory Inductance Plethysmography (RIP. This will occur in the operating room at the end of the surgery and anesthesia.)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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