Contact information
Type
Scientific
Primary contact
Dr Irfan Ulhaq Cheema
ORCID ID
Contact details
Box No 226
NICU
Rosie Maternity Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217 617 ext 6275
irfan.cheema@addenbrookes.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544139654
Study information
Scientific title
Acronym
Study hypothesis
To investigate if Pressure Support Ventilation (PSV) performs as well as conventional trigger ventilation modes synchronised intermittent mandatory ventilation (SIMV) and synchronised intermittent positive pressure ventilation (SIPPV), in supporting newborn infants receiving mechanical ventilation.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Neonatal Diseases: Ventilation
Intervention
Consent would be sought to participate in the study.
The patient would be eligible to commence the study when in a stable condition with an inspired oxygen concentration of less than or equal to 60% and a decision made by the treating clinician to commence weaning from the ventilator.
Patients on the neonatal unit at The Rosie maternity hospital are ventilated on the synchronised triggered ventilation modes of either synchronised intermittent mandatory ventilation (SIMV) or synchronised intermittent positive pressure ventilation (SIPPV). If the patient is on SIMV, their mode of ventilation will be altered to SIPPV (provided the patient is receiving a supported respiratory rate of greater than 40 breaths per minute, this will be equivalent to SIMV). If the patient is originally ventilated on SIMV and hence changed to SIPPV, a 1 hour period will be allowed prior to commencing the study in order for the patient to settle.
Once the study begins each infant will be allocated randomly to a start mode, with half of the patients starting on SIPPV and the other half starting on pressure support ventilation (PSV).
PSV is a mode of ventilation which allows each patient breath to be both patient initiated and patient terminated, therefore the patient sets the duration of their own inspiratory time. Each patient breath is supported by the ventilator. In the conventional modes of ventilation, SIMV and SIPPV each breath is again supported and is patient initiated but is ventilator terminated, the patient receives a preset inspiratory time, set by the clinician.
The ventilator settings on changing from SIPPV to PSV will be left unchanged except the inspiratory time will be increased to 0.5 seconds during the PSV mode. This is a limit on the maximum inspiratory time and will allow for a sighing respiration. Changing a patient from SIPPV to PSV and vice versa only requires the pressing of a switch on the Dräger 8000 plus ventilator.
The patient will remain on the initial mode of ventilation for 60 minutes and will then change to the alternate mode of ventilation for another 60 minute period.
During the study the newborns will receive standard intensive care monitoring, this will include measures of their heart rate and blood pressure, in addition each infant will have continuous monitoring of their blood carbon dioxide and oxygen concentrations by a transcutaneous monitor. This is a small 0.5 cm diameter probe attached to the skin and is a standard piece of monitoring equipment in the intensive care setting. In addition to the physiological parameters mentioned, during the study the patients will be observed for their level of comfort. In a few cases to verify the reproducibility of our comfort scores a video of the newborns will be taken. They will be used solely for this purpose and will be destroyed following the study.
During the study, data will be collected directly from the ventilators to analyse subsequently for various ventilator dependent parameters.
After the 2 hour study period the patient will be continued on the ventilatory mode chosen by the clinician.
This study requires few additional procedures beyond the routine care carried out on the neonatal unit. A blood gas will be taken prior to commencing the study, but we will restrict the timing of our study to coincide with when this would be routinely required. Other 'procedures' additional to routine care would be the use of a transcutaneous monitor (if the infant did not have one already attached) and the collection of data from the Drager ventilator and patient monitor, both of which are completely non invasive.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/12/2003
Overall trial end date
18/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
19/12/2003
Recruitment end date
18/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Box No 226
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (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
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/16815649
Publication citations
-
Results
Cheema IU, Sinha AK, Kempley ST, Ahluwalia JS, Impact of volume guarantee ventilation on arterial carbon dioxide tension in newborn infants: a randomised controlled trial., Early Hum. Dev., 2007, 83, 3, 183-189, doi: 10.1016/j.earlhumdev.2006.05.013.