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
  Purpose

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.


Condition
Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Ventilation Generated by External Chest Pressure in Children

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394172

Contacts
Contact: Ban Tsui, MD, MSc 780-407-8861 btsui@ualberta.ca

Locations
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Principal Investigator: Ban C Tsui, M.D. M.Sc.         
Sub-Investigator: Sara Horne, B.Sc.(Hons)         
Sub-Investigator: Viv Ip, M.D.         
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01394172     History of Changes
Other Study ID Numbers: Pro00018804
Study First Received: July 6, 2011
Last Updated: November 7, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Alberta:
Tidal Volume
Pediatric
Difficult airway
Ventilation
Airway management

Additional relevant MeSH terms:
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014