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A Novel Method of Non-invasive Ventilation in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01394172
First received: July 6, 2011
Last updated: November 7, 2013
Last verified: August 2012

July 6, 2011
November 7, 2013
June 2011
August 2014   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01394172 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: Yes ]
Same as current
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A Novel Method of Non-invasive Ventilation in Children
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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).

Apnea
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact: Ban Tsui, MD, MSc 780-407-8861 btsui@ualberta.ca
Canada
 
NCT01394172
Pro00018804
No
University of Alberta
University of Alberta
Not Provided
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
University of Alberta
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP