Condition category
Respiratory
Date applied
26/03/2010
Date assigned
12/04/2010
Last edited
12/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrea Lomp

ORCID ID

Contact details

Imperial College
Department of Paediatrics
Norfolk Place
London
W21PG
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University of Stellenbosch (South Africa)

Sponsor details

Faculty of Health Sciences
Tygerberg Campus
Francie van Zigl Drive
Parow
Cape Town
7505
South Africa

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes