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

Primary Purpose

Deglutition Disorders, Intensive Care Unit Syndrome, Swallowing Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasogastric Tube removal during extubation
Yale Swallow Protocol
Classif Nasogastric Tube Management
Classic swallowing test
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deglutition Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'OrléansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2023
Last Updated
May 5, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT05795569
Brief Title
Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
Acronym
FIRST
Official Title
Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders, Intensive Care Unit Syndrome, Swallowing Disorder, Feeding or Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Nasogastric Tube removal during extubation
Intervention Description
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 Type
Diagnostic Test
Intervention Name(s)
Yale Swallow Protocol
Intervention Description
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 Type
Procedure
Intervention Name(s)
Classif Nasogastric Tube Management
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Classic swallowing test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to feeding resumption post extubation
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Reintubation rate
Description
Defined as the necessity to intubate a patient when he/she was once extubated during his/her stay.
Time Frame
Day 7
Title
Rate of acquired pneumonia in the intensive care unit
Description
Defined as a new pneumonia acquired after the first extubation
Time Frame
Day 28
Title
Weight loss during ICU stay
Description
Defined as the difference between admission and discharge weight
Time Frame
Day 28
Title
Undernutrition status
Description
Defined as the blood pre-albumin level
Time Frame
Day 7
Title
ICU lenght of stay
Description
Defined as the number of days of ICU stay
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelie DESPUJOLS
Phone
+33238744071
Email
aurelie.despujols@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecile FOSSAT, Pt
Organizational Affiliation
CHR Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile FOSSAT
Email
cecile.fossat@chr-orleans.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32739246
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.
Results Reference
background
PubMed Identifier
30841709
Citation
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.
Results Reference
background
PubMed Identifier
35765374
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.
Results Reference
background
PubMed Identifier
24033866
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.
Results Reference
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Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial

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