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Airway-occlusion duration during measurement of maximum inspiratory pressure with an unidirectional valve in unconscious and tracheotomized patients with stroke

Airway-occlusion duration during measurement of maximum inspiratory pressure with an unidirectional valve in unconscious and tracheotomized patients with stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076615
Enrollment
Unknown
Registered
2023-10-13
Start date
2023-10-14
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

stroke

Interventions

Test group:A one-way valve was used to plug the tube for 20 seconds and 40 seconds, respectively, and the maximum inspiratory pressure of the patient corresponding to the corresponding plugging time w

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) age = 18 years, (2) clinically diagnosed with ischemic and/or hemorrhagic stroke, (3) breathing with a tracheostomy tube, (4) duration of stroke range within one year after diagnosis, (5) Glasgow Coma Scale (GCS) scores=8, (6) able to breathe room air spontaneously for 10 sec and main the SpO2>90%, (7) able to tolerate the airway occlusion for at least 40 seconds and main the SpO2>90%, (8) medically stable, body temperature: 36~38°C, resting blood pressure: between 90~140/60~90 mmHg, resting HR between 50 and 100 bpm, BR: 12~26 bpm, oxygen saturation: 90%–100%

Exclusion criteria

Exclusion criteria: (1) patients on beta blockers; (2) uncontrolled hypertension, arrhythmia, or an unstable cardiovascular status as reflected by fluctuating blood pressure and heart rate, poor cardiac outcome, or require vasopressor drugs; (3) had a subarachnoid hemorrhage; (4) their relatives declined permission to participate. (5) unstable SpO2.

Design outcomes

Primary

MeasureTime frame
Maximum inspiratory pressure;

Secondary

MeasureTime frame
heart rate ;blood pressure;respiratory rate;oxygen saturation;stroke volume;cardiac output;

Countries

China

Contacts

Public ContactLIU Fang

Shenzhen Second People's Hospital

764453406@qq.com+86 136 0304 9475

Outcome results

None listed

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