Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
09/10/2014
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 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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes