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

Deglutition Disorders Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795569
• Other study ID #: CHRO-2022-15
• Secondary ID: 2022-A02605-38
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: Aurelie DESPUJOLS
• Phone: +33238744071
• Email: aurelie.despujols[@]chr-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Feeding and Eating Disorders
• Intensive Care Unit Syndrome
• Swallowing Disorder

Intervention

Procedure:
• Nasogastric Tube removal during extubation
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

Diagnostic Test:
• Yale Swallow Protocol
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).

Procedure:
• Classif Nasogastric Tube Management
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).

Diagnostic Test:
• Classic swallowing 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.

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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