Pressure Support Ventilation (PSV) or Synchronised Intermittent Mandatory Ventilation (SIMV) for weaning preterm infants on mechanical ventilation
| ISRCTN | ISRCTN74272142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74272142 |
| Secondary identifying numbers | Version 13, 29/12/2010 |
- Submission date
- 23/02/2011
- Registration date
- 08/03/2011
- Last edited
- 20/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Most premature infants need breathing support through a tube in their wind pipe. We know providing artificial breathing support can lead to long-term problems with the growth of the lungs. Although most clinicians would agree when to start breathing support for a preterm infant, there is as yet no consensus on when to reduce this support, also called ‘weaning on mechanical ventilation’. This study is investigating two different methods of ‘weaning’ breathing support in premature infants. Until recently, most units in the UK used synchronised intermittent mandatory ventilation (SIMV). SIMV matches a fixed number of breaths on the breathing support machine and over a period of time the fixed number of breaths is reduced before the breathing tube is taken out (extubation). However, advances in technology have led to newer modes of ventilation. One such mode is pressure support ventilation (PSV). In PSV the infant is in charge of all aspects of breathing. The medical team would only set the permissible pressure level to support the spontaneous breaths, so weaning on mechanical ventilation would only be to decrease the pressure support before the tube is taken out. In adults PSV is preferred as this is more comfortable.
Who can participate?
Preterm infants born between 23+0 weeks and 32 weeks gestation who were ventilated for at least 6 hours for Respiratory Distress Syndrome (RDS).
What does the study involve?
Participating infants are randomly allocated to one of the two modes of ‘weaning’ breathing support. It is usual for some infants to not tolerate the reduction in breathing support and ‘fail’. If at any stage the infant does not tolerate any of the weaning methods then the medical team assess them as per usual policy. All other aspects of their care are provided as per unit policy and current practice.
What are the possible benefits and risks of participating?
At present there is no perceived benefit or risk of one method over the other. However, at the end of the study both the groups would be compared to find out if there is a difference.
Where is the study run from?
University Hospital of North Tees and James Cook University Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2010 to May 2013
Who is funding the study?
University Hospital of North Tees (UK)
Who is the main contact?
Prof. Samir Gupta
samir.gupta@nth.nhs.uk
Contact information
Scientific
Neonatal Unit
University Hospital of North Tees
Hardwick Road
Stockton
TS19 8PE
United Kingdom
| Phone | +44 (0)16 4262 4250 |
|---|---|
| samir.gupta@nth.nhs.uk |
Scientific
Neonatal Unit
University Hospital of North Tees
Hardwick Road
Stockton
TS19 8PE
United Kingdom
| Phone | + 44 (0)16 4262 4248 |
|---|---|
| mallyaprashant@yahoo.com |
Study information
| Study design | Multi-centre randomised controlled 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 the contact details to request a patient information sheet |
| Scientific title | Pressure Support Ventilation (PSV) or Synchronised Intermittent Mandatory Ventilation (SIMV) for weaning preterm infants on mechanical ventilation: a multi-centre randomised controlled trial |
| Study acronym | POST-UK Study |
| Study hypothesis | The trial is investigating the practicability of PSV as opposed to SIMV for weaning on mechanical ventilation in preterm infants needing mechanical ventilatory support for Respiratory Distress Syndrome (RDS). The primary endpoint of the trial is defined as time from entry into the trial (predefined priori of mean airway pressure of less than 10cm, oxygen requirement of less than 40% and spontaneous breath rates of at least 50%) to the time when the infant is ready for extubation demonstrated by passing then minute ventilation test (MVT). The null hypothesis for the trial would find no difference between the two modes. However any difference between the two modes would be calculated using appropriate statistical calculations. The study is planned across two tertiary care units in the North East of England. |
| Ethics approval(s) | Newcastle and North Tyneside Research Ethics Committee, 10/01/2011 |
| Condition | Respiratory distress syndrome in preterm babies |
| Intervention | The intervention arm would receive pressure supported mechanical breaths for all the spontaneous breaths generated by the infant and the control arm would receive SIMV mode of respiratory support as is currently practiced. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The primary endpoint is duration of weaning on mechanical ventilation - defined as time from commencing weaning in the assigned mode of respiratory support to the time when the infant is ready for extuabtion demonstrated by passing the MVT |
| Secondary outcome measures | 1. Total duration of mechanical support through the endotracheal (ET) tube 2. Total duration of respiratory support including non invasive respiratory support 3. Discharge on home oxygen 4. Complications of prematurity |
| Overall study start date | 26/01/2011 |
| Overall study end date | 26/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 110 |
| Participant inclusion criteria | 1. Preterm infants with RDS, stratified into three groups (23+0 to 25+6, 26+0 to 28+6 and 29+0 to 31+6 weeks) based on their gestation at birth would be enrolled if they are needing mechanical ventilation through an endotracheal tube for at least 6 hours 2. Signed parental consent is obtained before randomisation |
| Participant exclusion criteria | 1. Severe congenital malformation 2. Neuromuscular disorder demonstrated clinically with decreased muscular tone 3. Upper airway anomaly 4. Infants transferred from other unit who have met the study entry criteria on admission to the neonatal unit |
| Recruitment start date | 26/01/2011 |
| Recruitment end date | 26/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
TS19 8PE
United Kingdom
Sponsor information
Hospital/treatment centre
Univeristy Hospital of North Tees
Hardwick Road
Stockton
TS19 8PE
England
United Kingdom
| Phone | +44 (0)16 4238 3251 |
|---|---|
| jane.greenaway@nth.nhs.uk | |
"ROR" |
https://ror.org/04zzrht05 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 20/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Data analysis is ongoing. All aspects of the study would be sent for publication including the study protocol. The researchers aim to disseminate the research findings in 2018. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a repository. |
Editorial Notes
20/11/2017: Intention to publish date updated.
