Effect of airway clearance device on function and quality of life in stable ICU patients.

Not yet recruiting

Conditions: Respiratory disorders in diseasesclassified elsewhere,

Registration Number: CTRI/2022/12/048008

Lead Sponsor: MGM College of Physiotherapy

Brief Summary: Respiratory dysfunction is observed in ICU survivors owing to the pathophysiological consequences resulting in retained secretion, increased airway resistance, hypoxemia, atelectasis and respiratory failure. Furthermore, retained airway secretion is considered as one of factor that delays and/ or is considered as a major predictor of extubation failure.Numerous studies support the efficacy of early physiotherapy intervention in ICU patients in improving airway clearance, ventilatory parameters such as oxygen saturation, gas exchange and lung volume as well as augment weaning and extubation success. Positive Expiratory Pressure (PEP) devices has been reported to be effective in improving pulmonary function such as airway clearance and oxygenation. AirPhysio is a validated handheld Oscillating-Positive Expiratory Pressure (O-PEP) device which helps to improve bronchial hygiene, increases lung capacity through generation of positive pressure in the airways during expiration and by optimizing collateral ventilation. However, there is dearth of literature evaluating the long-term effects of O-PEP device in ICU survivors.Thus, our study aims to assess the effect of four weeks of use of Air-Physio device on lung function, physical performance, functional capacity and Health Related of Quality of Life (HRQoL) in ICU survivors.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

(1)Patients who are spontaneously breathing or on non-invasive ventilatory support in intensive care unit (2) Patients extubated for more than 8 hours who were previously intubated (3) Patients showing radiographic changes of sputum retention, consolidation and pulmonary infiltrates (4) Patients who are above 18 years (5) Patient who consent to participate.

Exclusion Criteria

(1)Patients who are hemodynamically unstable (2)Patients with untreated pneumothorax, emphysematous bullae, rib fractures etc (3)History of any recent major cardiac and neurosurgery (4)Patients who are tracheostomized during the ICU stay (5)Any neuro-musculoskeletal disorder that prevents them from performing the tests (6)Patients with cognitive impairment that prevents them from understanding the instructions (7)Patients who are agitated or sedated as assessed using Richmond Agitation Sedation Scale (RASS more than -1 or +1) (8)Participant who are not willing to participate.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(3)Functional capacity : Repetitions in 30 seconds Sit to Stand test	At Baseline \| At 4 weeks
(4)Quality of Life: EQ 5D 3L questionnaire score	At Baseline \| At 4 weeks
Primary outcome/s(1)Lung function : Pulmonary function (FEV1, FVC) , Respiratory muscle strength (Maximal Inspiratory Pressure, Maximal Expiratory Pressure),	At Baseline \| At 4 weeks
Chest expansion (at three levels namely axilla, nipple and xiphisternum)	At Baseline \| At 4 weeks
Sputum quantity would be assessed by measuring the sputum volume.	At Baseline \| At 4 weeks
(2)Physical performance: Short Physical Performance Battery test score	At Baseline \| At 4 weeks

Secondary Outcome Measures

Name	Time	Method
(1)Sarcopenia using SARC-calf scale.	(2)Frailty using Fried Frailty Index.

Trial Locations

Locations (1): MGM Hospital
🇮🇳
Raigarh, MAHARASHTRA, India
MGM Hospital
🇮🇳Raigarh, MAHARASHTRA, India
Shruti Nair
Principal investigator
9769323125
shrutinair@mgmcopnm.edu.in