A Novel Method of Non-invasive Ventilation in Children

August 11, 2015 updated by: University of Alberta

Non-invasive Ventilation Generated by External Chest Pressure in Children

The purpose of this study is to quantify the tidal volume generated by the pressure release immediately following the application of pressure to the chest.

Study Overview

Status

Completed

Conditions

Detailed Description

Airway management in the pediatric population differs from the adult population because of differences in their respiratory physiology and anatomy. For example the oxygen consumption is about three times higher in children as compared to adults; therefore, if there is a problem ventilating a child there is a higher impact on oxygen delivery and oxygen reserve. Current guidelines recommend that in respiratory emergencies where one "cannot ventilate and cannot intubate" that a cricothyroidectomy (insertion of a needle through the cricothyroid membrane in the neck) be performed. This procedure is very invasive and difficult to perform, especially in a small child. Since timing and simplicity are essential to successful airway management it is hypothesized that the investigators could utilize the physiological principles behind breathing to ventilate these children using the release of applied pressure to their chest. During, inspiration, the vertical and transverse dimensions of the thorax are increased, generating a negative pressure between the intrapleural space and the chest wall, allowing for air to be drawn into the lungs. As children have a very compliant rib cage one of the theoretical ways to improve lung inflation is to apply external pressure on the chest. The intrathoracic pressure increases above atmospheric pressure and air preferentially flows out of the lungs according to the pressure gradient. When the pressure is released and the chest recoils passively, a negative intrathoracic pressure is generated, which allows for air to flow into the lungs according to the pressure gradient created. If a sufficient tidal volume is generated by the release of pressure from the chest this could potentially become a simple, non-invasive, life-saving technique in children with difficult airways. By adapting the principles described above, it is possible that tidal volume and therefore, gas exchange can take place on release of the pressure applied to the chest.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a prospective, cohort study with a sample size of approximately 100 pediatric patients. The population will be stratified equally into the following age groups: neonate (0-28 days or 44 post-conceptual weeks), infants (>1-12 months), toddlers (>12months-3 years), children (>3-8 years), pre-teen (>8-13 years) and adolescent (>13 years).

Description

Inclusion Criteria:

  • All pediatric patients under the age of 18 years old.
  • All patients requiring a general anesthetic with an endotracheal tube (whether the patient will be intubated with an endotracheal tube will be decided by the anesthesiologist responsible for the case)
  • ASA (American Society of Anesthesiologists Physical Status Classification) I to III

Exclusion Criteria:

  • Failure to obtain parental consent or patient assent when appropriate (in general children over 8 years old)
  • ASA (American Society of Anesthesiologists Physical Status Classification) IV
  • Patients with any cardiac pathology
  • Patients with any respiratory pathology
  • Patients with any form of chest deformity (examples being pectus excavatum, pectus carinatum, scoliosis)
  • Patients who had previous cardiac/thoracic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal volume (mL), as displayed by the Draeger Narkomed 6400 Anesthesia Machine, after release of manual chest compression
Time Frame: After induction of general anesthesia and until completion of surgery (within an average time of 30 mins to 4 hours)
One tidal volume is displayed on the Draeger machine immediately after the manual release of chest compression. This outcome is recorded 3 times in each patient after fast manual compressions (1-2 seconds each), with the process performed while the patient is both bag-mask ventilated and intubated.
After induction of general anesthesia and until completion of surgery (within an average time of 30 mins to 4 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
Force of compression (kg), as displayed by the Lafayette Manual Muscle Tester, measured during each manual chest compression
Time Frame: after induction of general anesthesia and during surgery (between 30 mins and 4 hours)
after induction of general anesthesia and during surgery (between 30 mins and 4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Ban Tsui, M.D., M.Sc., Department of Anesthesiology and Pain Medicine, University of Alberta
  • Study Director: Viv Ip, M.D., Department of Anesthesiology and Pain Medicine University of Alberta
  • Study Director: Sara Horne, B.Sc.(Hons), Department of Anesthesiology and Pain Medicine University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 6, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00018804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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