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Most premature babies have difficulty breathing at birth and need help (what we call resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world.
To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth and nose. The clinical team tries to achieve a good seal between the face and the mask. A problem of mask ventilation is that air can escape between the mask and the face (what we call mask leak). Currently, two different types of facemasks ("Laerdal mask" or "Fisher & Paykel mask") are routinely used in the delivery room at The Royal Alexandra Hospital.
The purpose of this study is to find out if one facemask is leaking less between the face and the mask.
We will use a Laerdal round mask (Laerdal, Stavanger, Norway) compared to a Fisher & Paykel (FP) (Fisher & Paykel Healthcare, Auckland, New Zealand) 'round' neonatal resuscitation mask. The two point top hold for Laerdal 'round' mask and the rim hold for the Fisher & Paykel mask.
A Respiratory Function Monitor will be placed between the face mask and the ventilation device. It uses a small (dead space 1 mL) flow sensor to measure gas flow in and out of a face mask. This signal is automatically integrated to provide inspired and expired tidal volume. The difference equals the leak from the face mask. It also calculates respiratory rate and minute ventilation, measures spontaneous inspirations and ventilation pressures. The signals of airway flow, tidal volumes, airway pressure, inspired oxygen concentration, temperature, blood pressure, oxygen saturation, heart rate will be digitised and recorded at 200Hz using the Spectra physiological recording program (a customised neonatal respiratory physiology program).
We will compare the % of mask leak within the two face masks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laerdal Mask | Active Comparator | Mask ventilation with a Laerdal face mask |
|
| F&P Mask | Experimental | Mask ventilation with a F&P face mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mask ventilation with a Laerdal face mask | Procedure | Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percentage of Leak | Primary outcome: Difference in percentage of Leak | during mask ventilation in the first 5 minutes after birth |
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Inclusion Criteria:
Exclusion Criteria:
Participants will be included in the first minutes after birth if they require mask ventilation for poor respiratory effort. Data will be collected from the Hospital chart until discharge at around 40 weeks gestation.
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| Name | Affiliation | Role |
|---|---|---|
| Georg Schmolzer, MD,PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18039750 | Background | Wood FE, Morley CJ, Dawson JA, Kamlin CO, Owen LS, Donath S, Davis PG. Improved techniques reduce face mask leak during simulated neonatal resuscitation: study 2. Arch Dis Child Fetal Neonatal Ed. 2008 May;93(3):F230-4. doi: 10.1136/adc.2007.117788. Epub 2007 Nov 26. | |
| 22101203 | Background | Chua C, Schmolzer GM, Davis PG. Airway manoeuvres to achieve upper airway patency during mask ventilation in newborn infants - An historical perspective. Resuscitation. 2012 Apr;83(4):411-6. doi: 10.1016/j.resuscitation.2011.11.007. Epub 2011 Nov 18. |
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The study used deferred consent approach. In this approach patient are randomized and asked to participant afterwards because of minimal risk to participation this study. Therefore there are a larger number of participant at the start date of the study and if they decline to participate a lower enrolled number.
March 2013 to September 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Laerdal Mask | Mask ventilation with a Laerdal face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group. |
| FG001 | F&P Mask | Mask ventilation with a F&P face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laerdal Mask | Mask ventilation with a Laerdal face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Percentage of Leak | Primary outcome: Difference in percentage of Leak | Posted | Median | Inter-Quartile Range | % (percentage of mass leak) | during mask ventilation in the first 5 minutes after birth |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laerdal Mask | Mask ventilation with a Laerdal face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death during Admissions | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Georg Schmolzer | Univeristy of Alberta | 7807354660 | georg.schmoelzer@me.com |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mask ventilation with a F&P face mask | Procedure | Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group. |
|
| 22056350 | Background | Schmolzer GM, Morley CJ, Wong C, Dawson JA, Kamlin CO, Donath SM, Hooper SB, Davis PG. Respiratory function monitor guidance of mask ventilation in the delivery room: a feasibility study. J Pediatr. 2012 Mar;160(3):377-381.e2. doi: 10.1016/j.jpeds.2011.09.017. Epub 2011 Nov 5. |
| 20547584 | Background | Schmolzer GM, Kamlin OC, O'Donnell CP, Dawson JA, Morley CJ, Davis PG. Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F393-7. doi: 10.1136/adc.2009.174003. Epub 2010 Jun 14. |
| BG001 | F&P Mask | Mask ventilation with a F&P face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 2 |
| 28 |
| 2 |
| 28 |
| 0 |
| 28 |
| EG001 | F&P Mask | Mask ventilation with a F&P face mask Mask ventilation with a Laerdal face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group. Mask ventilation with a F&P face mask: Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group. | 2 | 28 | 2 | 28 | 0 | 28 |
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