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

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.

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Key information

Conditions

Surgery Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuation of High Frequency Jet Ventilation (HFJV)

Other

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.

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.)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Acronym: RIP03

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Nov 27, 2012
Registry last updated: Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed