Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial (NCT05795569) | Clinical Trial Compass
CompletedNot Applicable
Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
France112 participantsStarted 2023-03-21
Plain-language summary
Post-extubation dysphagia (PED) is a frequent but still underestimated condition in the intensive care units (ICU). In the international literature, the manifestations and consequences of PED lead to intra- and post-intensive care comorbidities.
The exact etiology of PED is unknown, but considered multifactorial. Numerous causes, acquired during ICU, can lead to a delay in the reintroduction of intravenous nutrition, or even favor the development of inhalation pneumopathy. One of these causes is the presence of the nasogastric tube.
The incidence of ECD varies from 3 to 62%. Its presence impacts morbidity and mortality. Preventive strategies for PED have only been studied with questionable methodologies.
The goal of ICU therapists is to detect PED as early as possible in order to implement curative strategies such as adapted nutrition and early swallowing rehabilitation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Extubation prescribed by the attending physisian
* Intubation for more than 48 hours
* Presence of a nasogastric tube
* RASS score equal to 0 at the time of screening.
Exclusion Criteria:
* Gastric tube for gastric emptying (suction or bag)
* Inability to remain alert for prolonged periods of time for the swallow test
* Pre-existing dysphagia
* Patient fed by nasogastric tube or jejunostomy before ICU stay
* Tracheostomized patient
* Contraindication to a bed head elevation \> 30°.
* Contraindication to the resumption of feeding
* Pregnant or breastfeeding woman
* Decision to limit active therapies
* Protected person (under guardianship or curatorship) / Person under court protection
* Person not affiliated to a social security system
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether removing the nasogastric feeding tube right after extubation affects how quickly patients can start eating again — if I end up on a ventilator in the ICU, is leaving the feeding tube in or taking it out early something my care team would decide based on findings like these?
2The trial focused on swallowing difficulties after being taken off a ventilator, which is a real risk in ICU patients — how will my doctors monitor my ability to swallow safely once I'm extubated, and what signs would tell them I need the feeding tube to stay in longer?
3Since this was a randomized trial comparing two approaches to post-extubation feeding, does my hospital already have a standard protocol for this, or is the timing of tube removal still a decision made case by case?
4The study is now completed — has my doctor seen any results or publications from this trial that might influence how they'd manage my nutrition if I needed ICU care and mechanical ventilation?
5Given that swallowing disorders are one of the conditions this trial studied, what rehabilitation or speech therapy support would be available to me in the ICU if I had trouble swallowing after being taken off the ventilator?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.