NCT04791540

Brief Summary

In this pilot observational study the primary outcome is to assess, in a Respiratory Rehabilitation Unit, if there is an association between sarcopenia, assessed by handgrip strenght and BIA, and a delayed decannulation time in patients who underwent tracheostomy. Secondary outcomes are to assess if there is an association between an increased malnutrition risk (assessed by MUST), a poor nutritional status (assessed by GLIM criteria) and a delayed decannulation time and the gut microbiota composition.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 22, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

4.6 years

First QC Date

February 22, 2021

Last Update Submit

August 21, 2025

Conditions

Sarcopenia

Keywords

handgrip strenghtbioelectrical impedance analysis (BIA)respiratory rehabilitationtracheostomy decannulationgut microbiotaGLIM criteriaMUST

Outcome Measures

Primary Outcomes (2)

  • Change from admission in muscle mass at decannulation time

    Measurement of muscle mass with Bioelectrical Impedance Analysis (BIA).

    Respiratory Rehabilitation Unit admission (T0) and decannulation time (T1), an average of 10 days

  • Change from admission in hangrip strenght at decannulation time

    Measurement of handgrip strenght with a handheld dynamometer. Male cut-off: \<27 Kg Female cut-off: \<16 Kg

    Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

Secondary Outcomes (21)

  • Change from admission in Body Mass Index (BMI) score at decannulation time

    Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

  • Change from admission in Malnutrition Universal Screening Tool (MUST) score at decannulation time

    Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

  • Change from admission in nutritional status at decannulation time

    Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

  • Change from admission in Gut Microbiota (GM) composition at decannulation time

    Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

  • Protein C reactive (PCR)

    Respiratory Rehabiliation Unit admission (T0) and decannulation time (T1), an average of 10 days

  • +16 more secondary outcomes

Study Arms (1)

Patients with trachestomy

Patients, attending a respiratory rehabilitation program, who underwent tracheostomy decannulation

Diagnostic Test: handgrip strenghtDiagnostic Test: Bioelectrical Impedance Analysis (BIA)Diagnostic Test: MUSTDiagnostic Test: GLIMBiological: Gut microbiotaBiological: Blood SampleOther: Anthropometric measures

Interventions

handgrip strenghtDIAGNOSTIC_TEST

Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)

Patients with trachestomy
Bioelectrical Impedance Analysis (BIA)DIAGNOSTIC_TEST

Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)

Patients with trachestomy
MUSTDIAGNOSTIC_TEST

Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)

Patients with trachestomy
GLIMDIAGNOSTIC_TEST

Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)

Patients with trachestomy
Gut microbiotaBIOLOGICAL

A fecal sample obtained at admission (T0) and at decannulation time (T1)

Patients with trachestomy
Blood SampleBIOLOGICAL

A Blood sample obtained at admission (T0) and at decannulation time (T1)

Patients with trachestomy
Anthropometric measuresOTHER

Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)

Patients with trachestomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent tracheostomy before admission, attending a rehabilitation program

You may qualify if:

  • Signed informed consent from patients or legal guardians for patients unfit to plead
  • Presence of tracheostomy at admission

You may not qualify if:

  • Refusal
  • Pregnancy
  • Pace maker/implantable cardioverter
  • No legal guardians for patients unfit to plead

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Don Carlo Gnocchi

Florence, Italy, 50143, Italy

RECRUITING

Related Publications (7)

  • Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats AJS, Crivelli AN, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee, GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):207-217. doi: 10.1002/jcsm.12383.

    PMID: 30920778BACKGROUND

  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

    PMID: 31081853BACKGROUND

  • Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Manuel Gomez J, Lilienthal Heitmann B, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, M W J Schols A, Pichard C; ESPEN. Bioelectrical impedance analysis-part II: utilization in clinical practice. Clin Nutr. 2004 Dec;23(6):1430-53. doi: 10.1016/j.clnu.2004.09.012.

    PMID: 15556267BACKGROUND

  • Kutsukutsa J, Mashamba-Thompson TP, Saman Y. Tracheostomy decannulation methods and procedures in adults: a systematic scoping review protocol. Syst Rev. 2017 Dec 4;6(1):239. doi: 10.1186/s13643-017-0634-0.

    PMID: 29202866BACKGROUND

  • Ticinesi A, Nouvenne A, Cerundolo N, Catania P, Prati B, Tana C, Meschi T. Gut Microbiota, Muscle Mass and Function in Aging: A Focus on Physical Frailty and Sarcopenia. Nutrients. 2019 Jul 17;11(7):1633. doi: 10.3390/nu11071633.

    PMID: 31319564BACKGROUND

  • Toptas M, Yalcin M, Akkoc I, Demir E, Metin C, Savas Y, Kalyoncuoglu M, Can MM. The Relation between Sarcopenia and Mortality in Patients at Intensive Care Unit. Biomed Res Int. 2018 Feb 12;2018:5263208. doi: 10.1155/2018/5263208. eCollection 2018.

    PMID: 29789798BACKGROUND

  • Prado CM, Purcell SA, Alish C, Pereira SL, Deutz NE, Heyland DK, Goodpaster BH, Tappenden KA, Heymsfield SB. Implications of low muscle mass across the continuum of care: a narrative review. Ann Med. 2018 Dec;50(8):675-693. doi: 10.1080/07853890.2018.1511918. Epub 2018 Sep 12.

    PMID: 30169116BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Gastrointestinal MicrobiomeBlood Specimen Collection

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Chiara F Gheri, MD

    Fondazione Don Carlo Gnocchi Onlus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara F Gheri, MD

CONTACT

00390557393612cgheri@dongnocchi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 10, 2021

Study Start

June 9, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)