Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014138
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-06-21
Brief Title:
Volatile Sedation for Patients With the Acute Respiratory Distress Syndrome
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Effect of Volatile Sedation on Spontaneous Breathing During Mechanical Ventilation for Patients With the Acute Respiratory Distress Syndrome
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISO-DRIVE
Brief Summary:
This study will investigate how different types of routine sedation may affect patients 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
Detailed Description:
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 patients 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 patients already injured lungs
This study of 20 patients is designed to carefully measure the impact of inhaled sedation on the patients 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
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 patients 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 patients already injured lungs
This study of 20 patients is designed to carefully measure the impact of inhaled sedation on the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None