Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05491408
Status:
UNKNOWN
Last Update Posted:
2022-08-08
First Post:
2022-07-22
Brief Title:
Effect of Cough Assist Device in COPD Patients Admitted to Respiratory Intensive Care Unit at Assiut University Hospital
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Effect of Cough Assist Device in COPD Patients Admitted to Respiratory Intensive Care Unit at Assiut University Hospital
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
2 To detect any possible complications associated with the use of cough assist device
Detailed Description:
Effective cough is a protective mechanism against respiratory tract infections COPD patients may have impaired cough and a reduction in peak cough flowsPCF 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None