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

Centre Hospitalier Régional d'Orléans

Status

Enrolling

Conditions

Swallowing Disorder

Intensive Care Unit Syndrome

Deglutition Disorders

Feeding or Eating Disorder

Treatments

Procedure: Classif Nasogastric Tube Management

Diagnostic Test: Classic swallowing test

Procedure: Nasogastric Tube removal during extubation

Diagnostic Test: Yale Swallow Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT05795569

CHRO-2022-15

2022-A02605-38 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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"

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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