Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial

Study Overview
=================
Brief 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.

Detailed Description
-----------------
There are several tools available to diagnose PED. These assessment methods are numerous and not subject to consensus. There are expensive instrumental methods requiring experts, which allow for accurate diagnosis but cannot be routinely used at the ICU patient's bed. For the ICU patient, bed-side clinical assessments seem more appropriate. The Yale swallow protocol (YSP), is the most used test in the literature. Its sensitivity in predicting PED at 96.5%, a negative predictive value of 97.9% and a false negative rate of less than 2%, seem to make it the most suitable. Currently, no recommendations have been made by French or international ICU societies on the appropriate time or method for PED assessment. Regarding the treatment of PED, the literature shows that physiotherapy management would not significantly reduce its incidence, nor accelerate the resumption of per os feeding. No study has examined the impact of nasogastric tube removal combined with the use of a standardized swallow test on post-extubation ECD. For all these reasons, we plan to evaluate the interventional strategy consisting in removing the nasogastric feeding tube as soon as extubation, to carry out between 1 hour and 6 hours post extubation the Yale swallow protocol, to allow a resumption of feeding as soon as possible while screening the dysphagic patients. The research hypothesis is therefore: Systematic removal of the nasogastric tube during the extubation procedure associated with an early swallow test in the ICU allows an early per-os nutritional resumption in comparison with the classical strategy of nasogastric tube management and swallowing disorders assessment

Official Title
-----------------
Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial

Conditions
-----------------
Deglutition Disorders, Intensive Care Unit Syndrome, Swallowing Disorder, Feeding or Eating Disorder

Intervention / Treatment
-----------------
* Procedure: Nasogastric Tube removal during extubation
* Diagnostic Test: Yale Swallow Protocol
* Procedure: Classif Nasogastric Tube Management
* Diagnostic Test: Classic swallowing test


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention Group: Nasogastric tube removal upon extubation with protocolized PED screening Control Group: Conventional nasogastric tube management and PED screening strategy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Procedure: Nasogastric Tube removal during extubation<br>* The nurse in charge of the patient and under the cover of a medical prescription, will proceed to the systematic removal of the nasogastric tube during the extubation procedure<br>Diagnostic Test: Yale Swallow Protocol<br>* The dysphagia will be evaluated in a systematic way between 1 hour and 6 hours post-extubation with the help of the Yale Swallow Protocol (YSP) by the caregivers trained to the passing of the YSP (nurse or physiotherapist or ICU doctor).<br>|
| Active Comparator: Control Group<br> | Procedure: Classif Nasogastric Tube Management<br>* The removal of the nasogastric tube will not be performed during the extubation procedure and the time of removal will be left to the discretion of the attending physician (as currently performed in the unit).<br>Diagnostic Test: Classic swallowing test<br>* Post-extubation dysphagia will be assessed as we do in the unit. Currently, the caregivers in charge of the patient do a gel water test Nutrisens Hydra'Fruit level 4 when the attending physician prescribes it.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to feeding resumption post extubation | If the patient passes the YSP or the classic swallowing test, a per-os diet resumption will be started and we will record the time of passing the test as the time of per-os feeding resumption. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation rate | Defined as the necessity to intubate a patient when he/she was once extubated during his/her stay. | Day 7 | 
| Rate of acquired pneumonia in the intensive care unit | Defined as a new pneumonia acquired after the first extubation | Day 28 | 
| Weight loss during ICU stay | Defined as the difference between admission and discharge weight | Day 28 | 
| Undernutrition status | Defined as the blood pre-albumin level | Day 7 | 
| ICU lenght of stay | Defined as the number of days of ICU stay | Day 28 |