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

NCT01733446 | Completed DMC

• 1 other identifier: 816280
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Anesthesia

Keywords

High frequency jet ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard anesthesia regimen

NO INTERVENTION

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

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.

Other: Continuation of High Frequency Jet Ventilation (HFJV)

Interventions

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.

Continuation of High Frequency Jet Ventilation ( HFJV)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Joshua H Atkins, MD PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: November 27, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

US (1)