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

Not Applicable

Completed

• Conditions: Surgery; Anesthesia
• Interventions: Other: Continuation of High Frequency Jet Ventilation (HFJV)

• Registration Number: NCT01733446
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuation of High Frequency Jet Ventilation ( HFJV)	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.

Primary Outcome Measures

Name	Time	Method
spontaneous breathing	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.)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States