Deglutition DisordersFIRSTNCT05795569
Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
A study testing Nasogastric Tube removal during extubation, Yale Swallow Protocol and Classif Nasogastric Tube Management in people with Deglutition Disorders and Intensive Care Unit Syndrome, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders, Intensive Care Unit Syndrome, Swallowing Disorder
- What is being tested?
- Nasogastric Tube removal during extubation, Yale Swallow Protocol and Classif Nasogastric Tube Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2023to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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°.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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"
- Conditions
- Deglutition Disorders, Intensive Care Unit Syndrome, Swallowing Disorder, Feeding or Eating Disorder
- Being tested
- Nasogastric Tube removal during extubation, Yale Swallow Protocol, Classif Nasogastric Tube Management, Classic swallowing test
- Medical subject headings
- Deglutition Disorders, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric Tube removal during extubationProcedure or surgery
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
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).
Classif Nasogastric Tube ManagementProcedure or surgery
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Procedure: Nasogastric Tube removal during extubation; Diagnostic Test: Yale Swallow Protocol |
| Control Group | Active comparator | Not described Receives: Procedure: Classif Nasogastric Tube Management; Diagnostic Test: Classic swallowing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (5)
Reintubation rate
Defined as the necessity to intubate a patient when he/she was once extubated during his/her stay.
Measured: Day 7
Rate of acquired pneumonia in the intensive care unit
Defined as a new pneumonia acquired after the first extubation
Measured: Day 28
Weight loss during ICU stay
Defined as the difference between admission and discharge weight
Measured: Day 28
Undernutrition status
Defined as the blood pre-albumin level
Measured: Day 7
ICU lenght of stay
Defined as the number of days of ICU stay
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start21 Mar 2023
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: Nasogastric tube removal upon extubation with protocolized PED screening Control Group: Conventional nasogastric tube management and PED screening strategy.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecile FOSSAT, Pt, Principal investigator, CHR Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795569
- Sponsor's protocol ID
- CHRO-2022-15
- Other IDs
- 2022-A02605-38
- Acronym
- FIRST
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2023
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32739246Leder 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.
PubMed 30841709Zuercher 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.
PubMed 35765374Warner 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.
PubMed 24033866
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05795569
- Acronym / sponsor ID
- FIRST / CHRO-2022-15
- Conditions
- Deglutition Disorders, Intensive Care Unit Syndrome, Swallowing Disorder, Feeding or Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Group: Nasogastric tube removal upon extubation with protocolized PED screening Control Group: Conventional nasogastric tube management and PED screening strategy.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Nasogastric Tube removal during extubation, Diagnostic Test: Yale Swallow Protocol |
| Control Group | Active comparator | Procedure: Classif Nasogastric Tube Management, Diagnostic Test: Classic swallowing test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasogastric Tube removal during extubationThe 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 | Procedure or surgery | Intervention Group |
| Yale Swallow ProtocolThe 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). | Diagnostic test | Intervention Group |
| Classif Nasogastric Tube ManagementThe 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). | Procedure or surgery | Control Group |
| Classic swallowing testPost-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. | Diagnostic test | Control Group |
Primary outcome
Time to feeding resumption post extubation
Time frame: 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.
5 secondary outcomes
Reintubation rate
Time frame: Day 7
Rate of acquired pneumonia in the intensive care unit
Time frame: Day 28
Weight loss during ICU stay
Time frame: Day 28
Undernutrition status
Time frame: Day 7
ICU lenght of stay
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 32739246McIntyre 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.
- Background: PubMed 30841709Leder 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.
- Background: PubMed 35765374Zuercher 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.
- Background: PubMed 24033866Warner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecile FOSSAT, Pt principal investigator
CHR Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasogastric Tube removal during extubation, Yale Swallow Protocol and Classif Nasogastric Tube Management in people with Deglutition Disorders and Intensive Care Unit Syndrome, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to feeding resumption post extubation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05795569, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.