Pressure Support ventilation: Short term physiological effects in neonates during weaning from intermittent positive pressure ventilation (IPPV)

ISRCTN ISRCTN52373519
DOI https://doi.org/10.1186/ISRCTN52373519
Secondary identifying numbers N0544139654
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
09/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Irfan Ulhaq Cheema
Scientific

Box No 226
NICU
Rosie Maternity Hospital
Cambridge
CB2 2QQ
United Kingdom

Phone +44 (0)1223 217 617 ext 6275
Email irfan.cheema@addenbrookes.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNeonatal Diseases: Ventilation
InterventionConsent 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date19/12/2003
Completion date18/12/2006

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment19/12/2003
Date of final enrolment18/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Box No 226
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2007 Yes No