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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

112

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

March 21, 2023

Completed

Same day until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed

13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

March 21, 2023

Last Update Submit

December 22, 2025

Conditions

Intensive Care Unit Syndrome Swallowing Disorder Feeding or Eating Disorder Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

Reintubation rate
Day 7
Rate of acquired pneumonia in the intensive care unit
Day 28
Weight loss during ICU stay
Day 28
Undernutrition status
Day 7
ICU lenght of stay
Day 28

Study Arms (2)

Intervention Group

EXPERIMENTAL

Procedure: Nasogastric Tube removal during extubationDiagnostic Test: Yale Swallow Protocol

Control Group

ACTIVE COMPARATOR

Procedure: Classif Nasogastric Tube ManagementDiagnostic Test: Classic swallowing test

Interventions

Classif Nasogastric Tube ManagementPROCEDURE

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).

Control Group

Classic swallowing testDIAGNOSTIC_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.

Control Group

Nasogastric Tube removal during extubationPROCEDURE

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

Intervention Group

Yale Swallow ProtocolDIAGNOSTIC_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).

Intervention Group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Centre Hospitalier Régional d'Orléanslead

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (4)

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.
PMID: 32739246BACKGROUND
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.
PMID: 30841709BACKGROUND
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.
PMID: 35765374BACKGROUND
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.
PMID: 24033866BACKGROUND

MeSH Terms

Conditions

Deglutition DisordersFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

Cecile FOSSAT, Pt
CHR Orleans
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

March 21, 2023

Primary Completion

April 10, 2025

Study Completion

April 10, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing: Will not share

Locations

FR(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Intervention Group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations