InSpiratory muscle Training in the tRacheOtomised critically ill adult – a prospective, siNGle-centre obsERvational study - STRONGER

InSpiratory muscle Training in the tRacheOtomised critically ill adult – a prospective, siNGle-centre obsERvational study - STRONGER - STRONGER

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016075

Enrollment

Registered

2019-01-09

Start date

2019-01-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G62.80 G72.80 J98.6

Interventions

Group 1: In all tracheotomized patients, inspiratory muscle training (IMT) is performed by means of an inspiratory resistance (e.g. threshold) or by a temporary change in trigger sensitivity at the re

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age > 18 years - tracheotomy - IMT treatment as part of clinical routine

Exclusion criteria

Exclusion criteria: - Spinal injuries higher than Th 8 - Existing / known complete diaphragmatic pareses - Tracheotomy due to ear, nose and throat problem (ENT problem) - Expected palliative treatment (comfort therapy) - Opposition to the General Consent

Design outcomes

Primary

Measure	Time frame
Frequency of clinical intolerance observed during all inspiratory muscle training sessions. - Newly occurring saturation loss SpO2 35 - new haemodynamically relevant blood pressure drops (MAP<50 mmHg) - rhythm disorder - cardiac arrest - accidental decannulation - airway obstruction	—

Secondary

Measure	Time frame
feasibility study - Number of all trainings at which the minimum requirement (1x6 repetitions with at least 9cmH2O resistance) can be met. (Documentation of the limiting factors in case of aborting or falling below the minimum requirements) - Number of all patients who meet the requirements for IMT and perform at least 1 workout with the minimum requirements. - Number of days per patient on which IMT can be performed (documentation Number of training sequences performed and limiting factor for not performed training) - Documentation Dosage and duration of the training sequences carried out Observation of clinical/functional changes (before, during and after IMT) - Duration of ventilation/stay in intensive care unit and in the Inselspital as a whole - Change of maximum inspiratory pressure (MIP) - Functional course: Medical Research Council Sum Score (MRC-SS), ICU Mobility Scale (IMS) and Chelsea critical care physiotherapy assessment tool (CPAx) - Clinical course: mortality to hospital discharge / transfer	—

Measure

Time frame

feasibility study - Number of all trainings at which the minimum requirement (1x6 repetitions with at least 9cmH2O resistance) can be met. (Documentation of the limiting factors in case of aborting or falling below the minimum requirements) - Number of all patients who meet the requirements for IMT and perform at least 1 workout with the minimum requirements. - Number of days per patient on which IMT can be performed (documentation Number of training sequences performed and limiting factor for not performed training) - Documentation Dosage and duration of the training sequences carried out Observation of clinical/functional changes (before, during and after IMT) - Duration of ventilation/stay in intensive care unit and in the Inselspital as a whole - Change of maximum inspiratory pressure (MIP) - Functional course: Medical Research Council Sum Score (MRC-SS), ICU Mobility Scale (IMS) and Chelsea critical care physiotherapy assessment tool (CPAx) - Clinical course: mortality to hospital discharge / transfer

—

Countries

Switzerland

Contacts

Public ContactAngela Kindler

Physiotherapie, Universitätsklinik Bern

angela.kindler@insel.ch0316322111

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026