Effect of Cough Assist Device in COPD Patients Admitted to Respiratory Intensive Care Unit at Assiut University Hospital

NCT05491408 | Unknown

• 1 other identifier: cough assist device in ICU
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To evaluate the effecacy of cough assist device (CAD) in COPD patients admitted in RICU either on invasive or Non-invasive ventilation.
2. 2.To detect any possible complications associated with the use of cough assist device.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• efficacy of Cough Assist Device (CAD) in COPD patients admitted in RICU including need for invasive or Non-invasive ventilation and weaning success.

  number of COPD patients who are on NIV that no further in need for MV after use of cough assist device will be calculated also number of COPD patients who are on MV , we will assess early weaning , rate of mortality among them after use of cough assist device in this group of patients

  Baseline

Study Arms (2)

patients exposed to cough assist device

the first group will include patients with COPD who received conventional management in addition to cough assist device

Device: Cough assist device

patients not exposed to cough assist device

the second group will include COPD patients who received conventional management only.

Interventions

Cough assist device DEVICE

A device that facilitates airway secretion clearance in COPD patients, thus avoiding hospitalisations and preventing pneumonias and episodes of respiratory failure \[4,5\].

patients exposed to cough assist device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Patient Will be subjected to: 1. Detailed clinical history \&physical examination. 2. Hemodynamics assessment. 3. GCS assessment. 4. Routine investigations. 5. Using Cough Assisted device in the first group: Settings of the Cough Assist device (inhale, exhale pressure, insufflation time, inhale flow). 6. Clinical assessment of patients before and after use of CAD including : RR, intensity of rhonchi and crepitations accessory muscle use,asynchrony with the machine either invasive or non-invasive. 7. ABG before and after use CAD 8. Physiological assessment of the patient including PEEP, plateau pressure, resistance and compliance before and after application of CAD in mechanically ventilated patients. 9. Calculation the amount of secretion before and after using CAD. 10. The duration of MV and the length of RICU stay will recorded. 11. Any possible complications will be recorded including drop in oxygen levels, barotrauma elevated blood pressure.

You may qualify if:

• All COPD patients above 18 years old who admitted to RICU.

You may not qualify if:

• All patients who have: neuromuscular diseases, pulmonary oedema, cardiac arrest, cardiogenic shock, acute myocardial infarction, pneumothorax, pulmonary neoplasm, pulmonary thromboembolism.

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Ebtesam Adel, MD

CONTACT

01012089691; ebtesam6569@gmail.com

Maha Kamel Ghanem / Hoda Makhlouf / Ali abdelazeem, Professor

CONTACT

20 122 769 4434; mahaghanem@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 8, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 8, 2022

Record last verified: 2022-08