ApneaNCT01394172
A Novel Method of Non-invasive Ventilation in Children
An observational study of Apnea, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Apnea
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Apnea
- Keywords
- Tidal Volume, Pediatric, Difficult airway, Ventilation, Airway management
- Medical subject headings
- Apnea, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After induction of general anesthesia and until completion of surgery (within an average time of 30 mins to 4 hours)
Secondary outcomes (1)
Force of compression (kg), as displayed by the Lafayette Manual Muscle Tester, measured during each manual chest compression
Measured: after induction of general anesthesia and during surgery (between 30 mins and 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ban Tsui, M.D., M.Sc., Principal investigator, Department of Anesthesiology and Pain Medicine, University of AlbertaViv Ip, M.D., Study director, Department of Anesthesiology and Pain Medicine University of AlbertaSara Horne, B.Sc.(Hons), Study director, Department of Anesthesiology and Pain Medicine University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394172
- Sponsor's protocol ID
- Pro00018804
- Status last verified
- Aug 2015
- First submitted
- 6 Jul 2011
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams AJ. ABC of oxygen: assessing and interpreting arterial blood gases and acid-base balance. BMJ. 1998 Oct 31;317(7167):1213-6. doi: 10.1136/bmj.317.7167.1213. No abstract available.
PubMed 9794863Adler SM, Wohl ME. Flow-volume relationship at low lung volumes in healthy term newborn infants. Pediatrics. 1978 Apr;61(4):636-40.
PubMed 662489Braga 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.
PubMed 19564271Tsui BC, Horne S, Tsui J, Corry GN. Generation of tidal volume via gentle chest pressure in children over one year old. Resuscitation. 2015 Jul;92:148-53. doi: 10.1016/j.resuscitation.2015.02.021. Epub 2015 Mar 4.
PubMed 25749553
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation Generated by External Chest Pressure in Children
- ClinicalTrials.gov ID
- NCT01394172
- Acronym / sponsor ID
- Pro00018804
- Conditions
- Apnea
- Keywords
- Tidal Volume, Pediatric, Difficult airway, Ventilation, Airway management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Background: PubMed 9794863Williams AJ. ABC of oxygen: assessing and interpreting arterial blood gases and acid-base balance. BMJ. 1998 Oct 31;317(7167):1213-6. doi: 10.1136/bmj.317.7167.1213. No abstract available.
- Background: PubMed 662489Adler SM, Wohl ME. Flow-volume relationship at low lung volumes in healthy term newborn infants. Pediatrics. 1978 Apr;61(4):636-40.
- Background: PubMed 19564271Braga 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.
- Derived from this study: PubMed 25749553Tsui BC, Horne S, Tsui J, Corry GN. Generation of tidal volume via gentle chest pressure in children over one year old. Resuscitation. 2015 Jul;92:148-53. doi: 10.1016/j.resuscitation.2015.02.021. Epub 2015 Mar 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban Tsui, M.D., M.Sc. principal investigator
Department of Anesthesiology and Pain Medicine, University of Alberta
Viv Ip, M.D. study director
Department of Anesthesiology and Pain Medicine University of Alberta
Sara Horne, B.Sc.(Hons) study director
Department of Anesthesiology and Pain Medicine University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01394172, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.