The INDURMAN Ventilation Study

• Research type

  Research Study

• Full title

  INtermittent breathing DURing MANdatory Ventilation: Can it Preserve Diaphragm Strength? (INDURMAN Ventilation Study)

• IRAS ID

  183957

• Contact name

  Philip Pemberton

• Contact email

  philip.pemberton@uhb.nhs.uk

• Sponsor organisation

  University Hospitals Birmingham NHS Foundation Trust

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  The longer a patient spends on a ventilator the smaller their chances of survival.
  Reduced strength in the main breathing muscle, the diaphragm is linked to the length of time a patient spends on a ventilator. It therefore follows that methods to reduce the loss of strength in the diaphragm, as well as better ways to help strengthen a weakened diaphragm may help patients to come off ventilators earlier.

  Several animal and limited human studies have shown that it is possible to limit the loss of strength in the diaphragm by allowing some normal breaths whilst on a ventilator.
  We will investigate whether intermittent stimulation of the diaphragm during mechanical ventilation is able to reduce the decrease in diaphragm strength in intensive care patients

  Neurally adjusted ventilatory assist (NAVA) is a mode of ventilation that measures a patients effort of breathing and adjusts the amount of help the ventilator gives during each breath according to patient effort. In those patients who are able to partly breathe on their own we will investigate if this automatic adjustment of ventilator help enables a quicker strengthening of the diaphragm in weaning patients.

  Patients expected to be ventilated for >48hrs will be randomised to one of two groups:

  i) Standard ventilation
  ii) Standard ventilation with intermittent magnetic stimulation of the diaphragm

  At the interim analysis (after recruitment of 50 patients) it will be decided whether or not to incorporate a pilot trial into this study.

  In the pilot study those patients that show a decrease in diaphragm strength of more than 30% will be further randomised to:
  i) Pressure support
  ii) NAVA
  for their weaning mode of ventilation.
  In all groups we will measure diaphragm muscle strength to assess if our interventions can reduce the loss in diaphragm strength and then increase the speed of gain of diaphragm strength in ventilated intensive care patients.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  16/EM/0035

• Date of REC Opinion

  30 Mar 2016

• REC opinion

  Further Information Favourable Opinion