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

Surgery Clinical Trial

— RIP03  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733446
• Other study ID #: 816280
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: April 20, 2018
• Start date: September 2012
• Est. completion date: February 2018

Study information

• Verified date: April 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or Female patients ages > 18 to < 80

2. Scheduled for procedures under general anesthesia with jet ventilation

3. Sign informed consent

4. Candidate for total intravenous anesthesia with propofol and remifentanil (which is standard protocol in this type of population)

Exclusion Criteria:

1. Absence of informed consent

2. No planned use intra-operative use of jet ventilation

3. Known difficulties with jet ventilation during prior surgical procedures

4. Emergency surgery

5. Baseline (oxygen saturation)SpO2 <92% on room air

6. BMI > 50

7. Pregnant or lactating females

8. Skin damage, rash or significant lesions in the areas covered by the RIP bands or transcutaneous CO2 sensor.

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spontaneous breathing	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.)	Day 0 in the operating room occurring in the specific time frame of the end of anesthesia to patient 's first breath