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

University of Pennsylvania

Status: Completed

Conditions: Surgery; Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01733446

816280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard anesthesia regimen

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Continuation of High Frequency Jet Ventilation (HFJV)