Deglutition Disorders Clinical Trial
— FIRSTOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHR d'Orléans | Orléans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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