A Novel Method of Non-invasive Ventilation in Children

Apnea Clinical Trial

Official title:

Non-invasive Ventilation Generated by External Chest Pressure in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394172
• Other study ID #: Pro00018804
• Status: Completed
• Phase: N/A
• First received: July 6, 2011
• Last updated: August 11, 2015
• Start date: June 2011
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Adler SM, Wohl ME. Flow-volume relationship at low lung volumes in healthy term newborn infants. Pediatrics. 1978 Apr;61(4):636-40. — View Citation

Braga MS, Dominguez TE, Pollock AN, Niles D, Meyer A, Myklebust H, Nysaether J, Nadkarni V. Estimation of optimal CPR chest compression depth in children by using computer tomography. Pediatrics. 2009 Jul;124(1):e69-74. doi: 10.1542/peds.2009-0153. — View Citation

Williams AJ. ABC of oxygen: assessing and interpreting arterial blood gases and acid-base balance. BMJ. 1998 Oct 31;317(7167):1213-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal volume (mL), as displayed by the Draeger Narkomed 6400 Anesthesia Machine, after release of manual chest compression	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)	No
Secondary	Force of compression (kg), as displayed by the Lafayette Manual Muscle Tester, measured during each manual chest compression		after induction of general anesthesia and during surgery (between 30 mins and 4 hours)	Yes