Clinical trial NCT05795569: Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
Official title: Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition Disorders
Intensive Care Unit Syndrome
Swallowing Disorder
Feeding or Eating Disorder
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group: Nasogastric tube removal upon extubation with protocolized PED screening Control Group: Conventional nasogastric tube management and PED screening strategy.
Primary purpose: TREATMENT

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"

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

Primary outcomes:
measure: Time to feeding resumption post extubation
timeFrame: Day 1
Secondary outcomes:
measure: Reintubation rate
timeFrame: Day 7
measure: Rate of acquired pneumonia in the intensive care unit
timeFrame: Day 28
measure: Weight loss during ICU stay
timeFrame: Day 28
measure: Undernutrition status
timeFrame: Day 7
measure: ICU lenght of stay
timeFrame: Day 28
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: CHR Orleans
name: Cecile FOSSAT, Pt
role: PRINCIPAL_INVESTIGATOR
References:
citation: McIntyre M, Doeltgen S, Dalton N, Koppa M, Chimunda T. Post-extubation dysphagia incidence in critically ill patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jan;34(1):67-75. doi: 10.1016/j.aucc.2020.05.008. Epub 2020 Jul 29.
citation: Leder SB, Warner HL, Suiter DM, Young NO, Bhattacharya B, Siner JM, Davis KA, Maerz LL, Rosenbaum SH, Marshall PS, Pisani MA, Siegel MD, Brennan JJ, Schuster KM. Evaluation of Swallow Function Post-Extubation: Is It Necessary to Wait 24 Hours? Ann Otol Rhinol Laryngol. 2019 Jul;128(7):619-624. doi: 10.1177/0003489419836115. Epub 2019 Mar 6.
citation: Zuercher P, Moser M, Waskowski J, Pfortmueller CA, Schefold JC. Dysphagia Post-Extubation Affects Long-Term Mortality in Mixed Adult ICU Patients-Data From a Large Prospective Observational Study With Systematic Dysphagia Screening. Crit Care Explor. 2022 Jun 8;4(6):e0714. doi: 10.1097/CCE.0000000000000714. eCollection 2022 Jun.
citation: Warner HL, Suiter DM, Nystrom KV, Poskus K, Leder SB. Comparing accuracy of the Yale swallow protocol when administered by registered nurses and speech-language pathologists. J Clin Nurs. 2014 Jul;23(13-14):1908-15. doi: 10.1111/jocn.12340. Epub 2013 Sep 6.