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

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.

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders; Intensive Care Unit Syndrome; Swallowing Disorder; Feeding or Eating Disorder
• Intervention / Treatment: Procedure: Nasogastric Tube removal during extubation; Diagnostic test: Yale Swallow Protocol; Procedure: Classif Nasogastric Tube Management; Diagnostic test: Classic swallowing test

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45067
    • CHR d'Orléans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	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).
Active Comparator: Control Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Cecile FOSSAT, Pt, CHR Orléans

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Deglutition Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: CHRO-2022-15; 2022-A02605-38 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No