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Testing of a modified deep breathing exercise device in tracheostomized patients

Effectiveness of a modified spirometry device in improving respiratory parameters in tracheostomised patients who underwent head and neck surgery: A non-randomized, safety and feasibility pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030584
Enrollment
25
Registered
2021-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Modified Incentive spirometry: 6h, 12h, 24h, 36h, 48h, 60h, 72h Control Intervention1: standard Incentive spirometry: 6h, 12h, 24h, 36h, 48h, 60h, 72h

Sponsors

All India Institute of Medical Sciences Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Recently tracheostomized(within 24 hours) 3. Postoperative head and neck surgery patients 4. Awake understands and follows a command

Exclusion criteria

Exclusion criteria: 1. Inability to comprehend and understand the process of incentive spirometry 2. Pregnant females 3. Patient with previously diagnosed COPD or other chronic lung diseases. 4. Patients with restrictive chest disease preoperatively 5. Patients with LRTI, Chest trauma, pneumothorax, head trauma preoperatively 6. Patients with haemodynamic instability and cardiac failure.

Design outcomes

Primary

MeasureTime frame
FVC, FEV1, PEFRTimepoint: 0h, 12h, 24h, 48h, 72h—

Secondary

MeasureTime frame
Hospital acquired pneumoniaTimepoint: 7 days—

Countries

India

Contacts

Public ContactHabib Md Reazaul Karim

All India Institute of Medical Sciences Raipur

praveenneema@gmail.com9612372585

Outcome results

None listed

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