Skip to main content
OpenTrials
Completed

NCT Number: NCT05795569

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasogastric Tube removal during extubation

Procedure

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

Yale Swallow Protocol

Diagnostic Test

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).

Classif Nasogastric Tube Management

Procedure

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).

Classic swallowing test

Diagnostic Test

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.

Primary outcomes

  1. Time to feeding resumption post extubation

    Time frame: Day 1

    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.

Secondary outcomes

  1. Reintubation rate

    Time frame: Day 7

    Defined as the necessity to intubate a patient when he/she was once extubated during his/her stay.

  2. Rate of acquired pneumonia in the intensive care unit

    Time frame: Day 28

    Defined as a new pneumonia acquired after the first extubation

  3. Weight loss during ICU stay

    Time frame: Day 28

    Defined as the difference between admission and discharge weight

  4. Undernutrition status

    Time frame: Day 7

    Defined as the blood pre-albumin level

  5. ICU lenght of stay

    Time frame: Day 28

    Defined as the number of days of ICU stay

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Acronym: FIRST

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.