A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration (RIP03)

This study is currently recruiting participants.

Verified November 2012 by University of Pennsylvania

Sponsor:

Information provided by (Responsible Party):

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01733446

First received: October 2, 2012

Last updated: November 26, 2012

Last verified: November 2012

History of Changes

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.)

Estimated Enrollment:	50
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Standard anesthesia regimen 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.)
Experimental: Continuation of High Frequency Jet Ventilation ( HFJV) 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.	Other: Continuation of High Frequency Jet Ventilation (HFJV) 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
BMI > 50
Pregnant or lactating females
Skin damage, rash or significant lesions in the areas covered by the RIP bands or transcutaneous CO2 sensor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733446

Contacts

Contact: Joshua H Atkins, MD PhD	215-662-4000	joshua.atkins@uphs.upenn.edu
Contact: Mary S Hammond, BSN	2156623772	mary.hammond@uphs.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Josh ua H Atkins, MD PhD 215-662-4000 joshua.atkins@uphs.upenn.edu
Contact: Mary S Hammond, BSN 2156623772 mary.hammond@uphs.upenn.edu
Principal Investigator: Joshua H Atkins, MDPhD
Sub-Investigator: Jeff Mandel, MD

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

Joshua H Atkins, MD PhD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01733446 History of Changes
Other Study ID Numbers:	816280
Study First Received:	October 2, 2012
Last Updated:	November 26, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

High frequency jet ventilation

Additional relevant MeSH terms:

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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