Measurements of work of breathing in newborn during respiratory support
| ISRCTN | ISRCTN86534610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86534610 |
| Secondary identifying numbers | 09.03.2008 / V1; AL002a |
- Submission date
- 26/03/2010
- Registration date
- 12/04/2010
- Last edited
- 12/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrea Lomp
Scientific
Scientific
Imperial College
Department of Paediatrics
Norfolk Place
London
W21PG
United Kingdom
Study information
| Study design | Randomised prospective clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Assessment and Measurement of Work of Breathing and Dynamic Lung Mechanics in Non-Invasive Respiratory Support: A prospective randomised controlled trial |
| Study acronym | nCPAP |
| Study objectives | 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(s) | The Research and Ethics Committee University of Stellenbosch, Parow, South Africa approved on the 7th of May 2008 (ref: N08/03/088) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2008 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Neonates requiring nCPAP 2. Weight less equal than 500g |
| Key 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 |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- England
- South Africa
- United Kingdom
Study participating centre
Imperial College
London
W21PG
United Kingdom
W21PG
United Kingdom
Sponsor information
University of Stellenbosch (South Africa)
Industry
Industry
Faculty of Health Sciences
Tygerberg Campus
Francie van Zigl Drive
Parow
Cape Town
7505
South Africa
"ROR" |
https://ror.org/05bk57929 |
|---|
Funders
Funder type
Charity
Save the Baby Charitable Trust (UK)
No information available
Sydney and Phyllis Goldberg Charitable Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
