Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09.03.2008 / V1; AL002a
Study information
Scientific title
Assessment and Measurement of Work of Breathing and Dynamic Lung Mechanics in Non-Invasive Respiratory Support: A prospective randomised controlled trial
Acronym
nCPAP
Study hypothesis
Study rationale:
This is the first study investigating changes in respiratory muscle work load of rib cage muscles, diaphragm and abdominal muscles at different levels of neonatal Continuous Positive Airway Pressure (nCPAP) in neonates and correlating those invasive measurements of work of breathing with respiratory parameters derived by non-invasive techniques.
Optimising work of breathing might improve ventilation strategies by avoiding respiratory muscle fatigue and respiratory muscle disuse atrophy. Additionally it might reduce energy expenditure, promoting weight gain and general development of the preterm infant and reduce the need for mechanical ventilation leading to a reduction in nosocomial infection, patient morbidity, hospital stay and cost.
Hypotheses:
Null Hypotheses
Respiratory muscle work load as measured by the pressure time product is not affected by changes in the level of nasal continuous positive airway pressure and does not correlate with changes in clinical parameters (respiratory rate, fraction of inspired oxygen and heart rate) and parameters derived by Respiratory Inductance Plethysmography (phase angle, abdominal excursion and expiratory time).
Alternative Hypotheses:
1. Respiratory muscle work load as measured by pressure time product is affected by changes in the level of nasal continuous positive airway pressure.
2. Changes in phase angle and expiratory time derived by non-invasive Respiratory Inductance Plethysmography correlate with changes in pressure time product derived by oesophageal gastric pressure transducer at different levels of nasal continuous positive airway pressure.
3. Reduction of pressure time product correlates with improvement of clinical parameters (heart rate, respiratory rate, fraction of inspired oxygen and peripheral oxygen saturation).
Aim and objectives:
The overall aim of the study was to investigate if work of breathing as measured by invasive techniques can be predicted by respiratory parameters derived by non-invasive techniques.
The objectives were:
1. To develop a monitoring system for the measurement of work of breathing in neonates on nCPAP.
2. To validate the new monitoring system.
3. To measure changes in pressure time products at different levels of nCPAP.
4. To determine the correlation between pressure time product derived by oesophageal gastric pressure transducer and phase angle and expiratory time derived by respiratory inductance plethysmography at different levels of nCPAP.
5. To determine whether there is a correlation between pressure time product and clinical parameter including respiratory rate, fraction of inspired oxygen, peripheral oxygen saturation and heart rate.
Ethics approval
The Research and Ethics Committee University of Stellenbosch, Parow, South Africa approved on the 7th of May 2008 (ref: N08/03/088)
Study design
Randomised prospective clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Respiratory Failure
Intervention
Each participant received nCPAP at pressure levels of 2, 4, 6 and 8 cm H2O. The sequence of the pressure levels for each subject was randomised to avoid a 'volume history effect' (an increase of lung volume with increased CPAP).
Lung function parameters were continuously measured at each CPAP level via Respiratory Inductance Plethysmography and Oesophageal Gastric Pressure Transducer. Measured parameters were oesophageal pressure, gastric pressure, phase angle, abdominal excursion, expiratory time, respiratory rate, fraction of inspired oxygen and heart rate.
The total duration of intervention is one hour, the participants are all on an intensive care or special care neonatal unit, therefore nurses and doctors will continuously record vital signs until the participant is discharged from the unit. The principal investigator is also the neonatal consultant on those wards and will be informed at any time if participants deteriorate shortly after the study (within 24 hours). Long term follow up is not planned.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Pressure time product
All outcome variables will be measured 10 -15 minutes after each change of nCPAP level for a period of 5 minutes
Secondary outcome measures
1. Phase angle
2. Abdominal excursion
3. Respiratory rate
4. Expiratory time
5. FiO2
All outcome variables will be measured 10 -15 minutes after each change of nCPAP level for a period of 5 minutes
Overall trial start date
01/06/2008
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Neonates requiring nCPAP
2. Weight less equal than 500g
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Parents refusing consent
2. Fraction of Inspired Oxygen (FiO2) > 0.5cc
3. Pneumothorax
4. Necrotizing Enterocolitis
5. Haemodynamically unstable
6. Imminent intubation
7. Weaning off CPAP
8. Major congenital malformation
Recruitment start date
01/06/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
South Africa
Trial participating centre
Imperial College
London
W21PG
United Kingdom
Funders
Funder type
Charity
Funder name
Save the Baby Charitable Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sydney and Phyllis Goldberg Charitable Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list