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

Not Applicable

Recruiting

• Conditions: Intensive Care Unit Syndrome; Swallowing Disorder; Feeding or Eating Disorder; Deglutition Disorders
• Interventions: Procedure: Nasogastric Tube removal during extubation; Procedure: Classif Nasogastric Tube Management; Diagnostic Test: Yale Swallow Protocol; Diagnostic Test: Classic swallowing test

• Registration Number: NCT05795569
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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"

Study Timeline

• Study Start: 2023-03-21
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Yale Swallow Protocol	-
Intervention Group	Nasogastric Tube removal during extubation	-
Control Group	Classif Nasogastric Tube Management	-
Control Group	Classic swallowing test	-

Primary Outcome Measures

Name	Time	Method
Time to feeding resumption post extubation	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 Outcome Measures

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

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France