Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382727
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-15
Brief Title:
CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care
Sponsor:
Emma Ridley
Organization:
The Alfred
Study Overview
Official Title:
CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care a Pilot Randomised Controlled Trial CONTINUE Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
CONTINUE
Brief Summary:
Critically ill patients admitted to the Intensive Care Unit ICU often need to be connected to a breathing machine ventilator and are unable to eat During this time liquid nutrition is delivered via a feeding tube to the stomach or bowel termed enteral nutrition EN to ensure nutrition needs are provided until such time that the patient can eat normally
The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube termed extubation
The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU There is currently no scientific consensus on whether pausing of EN is necessary or for how long Because of this some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN
This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation
The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube termed extubation
The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU There is currently no scientific consensus on whether pausing of EN is necessary or for how long Because of this some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN
This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation
Detailed Description:
The provision of EN is standard practice to mechanically ventilated patients within the ICU Delivery is frequently interrupted with patients often receiving approximately half of prescribed volumes One of the main contributors to this is fasting prior to extubation Fasting prior to extubation is historically informed from pre-anaesthetic practice in patients who are not critically ill where fasting allows for adequate gastric emptying and reduces the risk of aspiration on induction The practice of fasting prior to extubation is less informed and variable A recent scoping review identified only 1 randomised controlled trial RCT and 13 observational studies on this topic The review found fasting durations varied between 0-34 hours and the reasons for fasting prior to extubation were safety related however these reasons were often extrapolated from data outside of the ICU as outlined above The review concluded that there is an evidence gap and no evidence-based consensus as to the rationale and duration of fasting critically ill patients prior to extubation
The clinical consequences of fasting and particularly repeated fasting are not well understood however it is known that fasting leads to reduced nutrition which may negatively impact response to illness particularly in patients with a long length of stay Beyond this the requirement for fasting may delay extubation and progression of care as extubation may be cancelled if the patient is not adequately fasted and lead to unnecessary use for nursing and medical resources
The CONTINUE trial represents the first trial of its kind in Australia and seeks to determine feasibility to inform a program of research that addresses a universal practice for critically ill patients requiring mechanical ventilation Establishment of feasibility will provide data to inform a large RCT of similar nature powered to determine differences in important clinical outcomes such as reintubation rate ventilator free days to day 28 of admission and development of aspiration pneumonia The culmination of this research will be to create an evidence-based guideline on pre-extubation fasting with the aim of standardising and informing international practice
The primary aim is to determine whether continuing EN to the point of extubation and performing maximal nasogastric aspiration immediately prior is feasible and decreases total fasting in the time 24 hours prior to extubation compared to standard practice of ceasing EN 4- 6 hours prior to planned extubation in low risk ventilated patients Secondary objectives include assessment of important safety related endpoints including change in oxygenation requirements aspiration reintubation rate at 48 hours after extubation and clinical outcome measures including ICU and hospital morbidity and mortality
The clinical consequences of fasting and particularly repeated fasting are not well understood however it is known that fasting leads to reduced nutrition which may negatively impact response to illness particularly in patients with a long length of stay Beyond this the requirement for fasting may delay extubation and progression of care as extubation may be cancelled if the patient is not adequately fasted and lead to unnecessary use for nursing and medical resources
The CONTINUE trial represents the first trial of its kind in Australia and seeks to determine feasibility to inform a program of research that addresses a universal practice for critically ill patients requiring mechanical ventilation Establishment of feasibility will provide data to inform a large RCT of similar nature powered to determine differences in important clinical outcomes such as reintubation rate ventilator free days to day 28 of admission and development of aspiration pneumonia The culmination of this research will be to create an evidence-based guideline on pre-extubation fasting with the aim of standardising and informing international practice
The primary aim is to determine whether continuing EN to the point of extubation and performing maximal nasogastric aspiration immediately prior is feasible and decreases total fasting in the time 24 hours prior to extubation compared to standard practice of ceasing EN 4- 6 hours prior to planned extubation in low risk ventilated patients Secondary objectives include assessment of important safety related endpoints including change in oxygenation requirements aspiration reintubation rate at 48 hours after extubation and clinical outcome measures including ICU and hospital morbidity and mortality
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