Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510972
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Non-inferiority of a Strategy of Continuing Oral Intake Compared With Fasting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-inferiority of a Strategy of Continuing Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure at Risk of Tracheal Intubation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JEUN-TUBE
Brief Summary:
Fasting in the intensive care unit is a crucial issue and has been studied in particular in patients on mechanical ventilation or at the time of weaning To date there are no data on fasting in patients with acute respiratory failure hospitalised in the intensive care unit but not intubated
The nutritional attitude to adopt in these patients is not mentioned in the recommendations on nutrition for intensive care patients even though it has been proven in the literature that this specific category of patients does not achieve the theoretical calorie targets particularly as a large proportion of these patients are not fed whether orally or per os enteral via a naso- or oro-gastric tube or parenterally There is therefore a real rationale for trying to maintain a nutritional intake in patients with acute respiratory failure
One of the fears of the team caring for a patient in acute respiratory failure is the potential occurrence of false routes
In addition to false routes orotracheal intubation of patients requiring mechanical ventilation in intensive care presents a risk of inhalation of gastric contents followed by the potential development of pneumonia
In the clinical setting inhalation may not be symptomatic but may progress to severe pneumonia and acute respiratory distress syndrome pulmonary fibrosis and therefore be life-threatening
By analogy in intensive care patients at risk of intubation are put on a fast as a preventive measure to limit the risk of a false route and the risk of potential inhalation in the event of intubation This practice which is very common on admission to intensive care and continuous care units has not been studied in the literature and is not the subject of recommendations
Finally patients hospitalised in intensive care are subject to numerous discomforts
The hypothesis put forward is that the continuation of intravenous fluids in intensive care units for patients at risk of intubation does not increase the need for intubation and does not increase adverse effects such as false routes or inhalation of gastric contents in patients who ultimately require intubation
The nutritional attitude to adopt in these patients is not mentioned in the recommendations on nutrition for intensive care patients even though it has been proven in the literature that this specific category of patients does not achieve the theoretical calorie targets particularly as a large proportion of these patients are not fed whether orally or per os enteral via a naso- or oro-gastric tube or parenterally There is therefore a real rationale for trying to maintain a nutritional intake in patients with acute respiratory failure
One of the fears of the team caring for a patient in acute respiratory failure is the potential occurrence of false routes
In addition to false routes orotracheal intubation of patients requiring mechanical ventilation in intensive care presents a risk of inhalation of gastric contents followed by the potential development of pneumonia
In the clinical setting inhalation may not be symptomatic but may progress to severe pneumonia and acute respiratory distress syndrome pulmonary fibrosis and therefore be life-threatening
By analogy in intensive care patients at risk of intubation are put on a fast as a preventive measure to limit the risk of a false route and the risk of potential inhalation in the event of intubation This practice which is very common on admission to intensive care and continuous care units has not been studied in the literature and is not the subject of recommendations
Finally patients hospitalised in intensive care are subject to numerous discomforts
The hypothesis put forward is that the continuation of intravenous fluids in intensive care units for patients at risk of intubation does not increase the need for intubation and does not increase adverse effects such as false routes or inhalation of gastric contents in patients who ultimately require intubation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None