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

NCT ID: NCT01733446

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Surgery Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.)

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Continuation of High Frequency Jet Ventilation (HFJV)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua H Atkins, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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816280

Identifier Type: -

Identifier Source: org_study_id

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