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Effects of a Threshold Trainer on Inspiratory Muscle Strength in Mechanically Ventilated Patients: A Randomized Controlled Trial

Effects of a Threshold Trainer on Inspiratory Muscle Strength in Mechanically Ventilated Patients: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR201909644273809
Enrollment
80
Registered
2019-09-30
Start date
2020-01-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Respiratory

Interventions

Standard Manual Chest Physiotherapy treatment

Sponsors

Kelebogile Montsho
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: I. Participants should be intubated for at least 48 hours on PSIMV, CPAP, BiPAP or T-piece. II. Participants should be on FiO2 of 50% and less, PEEP of 8cmH2O or less, SpO2 of 90% and above. III. Participants should be haemodynamically stable (with BP no less than 100/60 mmHg or more 150/90 mmHg, HR of no more 120 b/minute, temperature no more than 37.50C). IV. Conscious and able to respond to verbal commands with a GCS of 7/10 and above. V. Participants should be able to maintain a semi-fowler position for at least 15 minutes.

Exclusion criteria

Exclusion criteria: I. Participants will be excluded if they are haemodynamically unstable. II. Participants will be excluded if they have conditions that compromise inspiratory muscle training (e.g flail chest, neuropathies, myopathies, distended abdomen, open abdomen). III. Participants on sedatives or paralyzing medication at the time of assessment (propofol , dormicum, high levels of morphine etc) IV. Participants who cannot offer co-operation. V. Pain with a VAS of more than 8.

Design outcomes

Primary

MeasureTime frame
1. Maximal inspiratory pressure (MIP) Maximal inspiration pressure is an effective method for evaluating inspiratory muscle strength, thus giving the effect of It is used as a diagnostic tool , as a predictive mechanical index (Black et al., 1969) 2. Rapid shallow breathing index (RSBI) The rapid shallow breathing index is the known ration of respiratory rate and spontaneous tidal volume.

Secondary

MeasureTime frame
1.Rate of re-intubation For the purpose of this study, re-intubation is defined as any intubation after 48 hours following primary extubation, (Brueckmann, Villa-Uribe, Bateman, Grosse-Sundrup, Hess, Schlett, et al., 2013). The number of participants who will be re-intubated after successful extubation will be recorded and the rate of re-intubation will be calculated as a percentage of the total number of participants in either a control or experimental group. 2. Arterial Blood Gas Arterial blood gases will be recorded as per ICU protocol, changes in levels of arterial blood oxygen, carbon dioxide, saturation levels, and pH will be interpreted to show improvement in oxygenation of all participants, with interest in increased levels of CO2.

Countries

South Africa

Contacts

Public ContactSilmara Hanekom

Clinical trial supervisor

silmara.hanekom@gmail.com0123563084

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026