Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Location status: Recruiting
NCT Number: NCT06014138
This study will investigate how different types of routine sedation may affect patient's breathing whilst on a ventilator in the Intensive Care Unit (ICU). There are different approaches to sedation which may have advantages and disadvantages. During the study patients will receive both intravenous and inhaled volatile sedation (similar to anaesthetic 'gases' used for general anaesthesia) and the drive to breath, breathing efforts and function of the lung will be assessed.
Interested in participating?
Request Info17 year and older
All sexes
Interventional
Phase 2 / Phase 3
London, SE1 9RT, United Kingdom
Location status: Recruiting
It is routine for patients to be sedated for their comfort and safety whilst on a ventilator in the Intensive Care Unit (ICU). Conventionally sedatives are given intravenously, however inhaled volatile sedation is becoming more popular. Inhaled sedation has recently been approved by the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom (UK).
Whilst being on a ventilator can be life-saving, it can cause potential problems. It is important that the patient interacts well with the ventilator and that their own breathing efforts are well regulated. There is evidence that inhaled sedation can specifically help the lungs when patients have the Acute Respiratory Distress Syndrome (ARDS) and in particular, inhaled sedation does not appear to suppress patient's own breathing as much as conventional sedation. Greater spontaneous breathing by the patient is usually positive but needs to be carefully understood to ensure it is not excessive or damaging to the patient's already injured lungs.
This study of 20 patients is designed to carefully measure the impact of inhaled sedation on the patient's breathing and lung function, in comparison to intravenous sedation. Measurements will be taken whilst on intravenous sedation before the patient is switched to an equivalent level of inhaled sedation for six hours, when the measurements will be repeated. Finally, the patient will go back to their original intravenous sedation and the measurements taken again. This is called a 'cross-over' study and is a good way to evaluate the effect of the drug.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard care, propofol sedation - 2 hour periods of observation before and after inhaled volatile sedation
Inhaled volatile sedation for 6 hours - 2 hours wash in / wash out, followed by 4 hours of observations
Time frame: 8 hours
Negative pressure in the first 100milliseconds of inspiration (P0.1) - Physiological parameter
Time frame: 8 hours
End expiratory occlusion pressure (Pmus) - Physiological parameter
Time frame: 8 hours
Pressure Muscle Index (PMI) - Physiological parameter
Time frame: 8 hours
Oesophageal pressure swings - Physiological parameter
Time frame: 8 hours
Ratio of arterial partial pressure of oxygen to fractional inspired concentration of oxygen (PaO2:FiO2) - Physiological parameter
Time frame: 8 hours
Pulmonary shunt fraction (Qs/Qt) - Physiological parameter
Time frame: 8 hours
ratio of ventilatory 'dead space' to tidal volume (Vd/Vt) - Physiological parameter
Time frame: 8 hours
volume of carbon dioxide breathed out (VCO2) - Physiological parameter
Contact information is provided by the study sponsor or research team.
Gill Radcliffe
CONTACT
Guy Glover
CONTACT
Guy's and St Thomas' NHS Foundation Trust
Other
Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome
Acronym: ISO-DRIVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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