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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05491408
Other study ID # cough assist device in ICU
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date March 1, 2024

Study information

Verified date August 2022
Source Assiut University
Contact Ebtesam Adel, MD
Phone 01012089691
Email ebtesam6569@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

Effective cough is a protective mechanism against respiratory tract infections. COPD patients may have impaired cough and a reduction in peak cough flows(PCF) as a result of inspiratory and expiratory muscle weakness, which causes a reduction in the pressure available to drive the cough manoeuver. Cough augmentation with mechanical Insufflation-Exsufflation (MI-E) has been described as a technique that facilitates airway secretion clearance in COPD patients, thus avoiding hospitalisations and preventing pneumonias and episodes of respiratory failure . Cough augmentation techniques comprise lung volume recruitment, (also termed air stacking or breaths tacking), mechanically assisted cough using mechanical insufflation-exsufflation (MI-E) device. During lung volume recruitment, the person inhales a volume of gas via the ventilator, or self-inflating resuscitation bag adapted with a one-way valve to facilitate gas holding. The person retains the inhaled volume by closing the glottis, inhales another volume of gas and then again closes the glottis; this process is repeated until maximum insufflation capacity is reached MI-E devices deliver a positive (inflation) and negative pressure (rapid deflation) delivered to the person via an oronasal interface, mouthpiece, or endotracheal or tracheostomy tube. MI-E comprises a pressure -targeted lung insufflation followed by vacuum exsufflation, enabling lung emptying and increasing peak cough flow. Alternation of pressure may be manually or automatically cycled. Pressures of 40 mmHg (insufflation) to 40 mmHg (exsufflation) (54 cmH2O) are usually most effective and best tolerated by the person . Treatments usually comprise three to five insufflation-exsuflation cycles followed by a short period of rest to avoid hyperventilation. Treatments can be repeated until no further secretions are expectorated. MIE can be performed in isolation or in combination with manually assisted cough . Few complications associated with MI-E devices as a drop in oxygen levels, barotrauma elevated blood pressure for more than 30 minutes have been reported, most likely due to use of pressures that are much lower than physiological cough pressures and the short duration of application .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - All COPD patients above 18 years old who admitted to RICU. Exclusion Criteria: - • All patients who have: neuromuscular diseases, pulmonary oedema, cardiac arrest, cardiogenic shock, acute myocardial infarction, pneumothorax, pulmonary neoplasm, pulmonary thromboembolism.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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