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Cough Assist Device in Mechanically Ventilated Patients

Role of Cough Assist Device in Mechanically Ventilated Patients in Respiratory Intensive Care Unit : Assiut University Experience

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05480371
Enrollment
200
Registered
2022-07-29
Start date
2022-08-01
Completion date
2023-08-31
Last updated
2022-07-29

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

Conditions

Mechanically Ventilated Patients

Brief summary

Aspiration of respiratory secretions is a frequently needed procedure in intubated patients . Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough.There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways .Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough

Detailed description

Critically ill patients under invasive ventilation are at risk for sputum retention . Aspiration of respiratory secretions is a frequently needed procedure in intubated patients . Cough is an important defence mechanism to clear mucus from the upper and lower airways . The presence of an endotracheal tube impairs the ability to cough. This prevents the enhancement of cough velocity . Furthermore, critically ill patients frequently have an impaired or no cough reflex due to depressed levels of consciousness, sedation, muscle weakness or muscle paralysis. Sputum retention, resulting from an inability to cough effectively, is one cause of extubation failure which in turn is associated with increased mortality. There are a number of techniques to mobilise sputum and optimise airway clearance for invasively ventilated patients. Endotracheal suctioning is the most common intervention used to remove retained airway secretions from within the endotracheal tube, trachea and upper airways . Endotracheal suctioning though is not effective for clearing secretions from the lower airways . New technologies and advanced methods have been developed to increase the effectiveness of mucus clearance in patients with acute respiratory failure, including mechanical insufflation-exsufflation devices. This technique has been described as an effective aid for mucus clearance in patients with chronic muscle weakness or neuromuscular disease. Mechanical insufflation-exsufflation (MI-E) aids sputum clearance from upper and lower airways. This technique augments inspiratory and expiratory flows to improve sputum mobilisation, through the application of rapidly alternating positive and negative pressure, which approximates a normal cough .

Interventions

DEVICEConventional tracheal suctioning

Group 1 allocated to conventional tracheal suctioning,all patiemts will be followed up until discharge from ICU or death Tracheal suctioning will be performed following the American Association for Respiratory Care recommendations.

Group 2 will be allocated to mechanical insufflation-exsufflation which will be performed with the which will be applied 5 times in 5cough cycles in automatic mode, with insufflation and exsufflation pressures of + 40/-40 cmH2O, respectively. The duration of each phase was 3 s, without pause. Hyperoxygenation (100% O2) will be performed for 1 min before applying each technique and a 20 s interval will be allowed between repetitions.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients of both sexes on mechanical ventilation in RICU with any respiratory disease Mechanically ventilated Patients without facial trauma Mechanically ventilated Patients hemodynamically stable

Exclusion criteria

Patients diagnosed with barotrauma Patients diagnosed with pneumothorax History of bullous emphysema Known susceptibility to pneumothorax or pneumo-mediastinum

Design outcomes

Primary

MeasureTime frameDescription
Assess effects of MIE on blood pressur1 yearBlood pressure measuered in mmHg
Assess effects of MIE on Oxygen saturation1 year
Assess effects of MIE on heart rate1 yearHeart rate measured by beats per minute
Assess effects of MIE on Volume of Secretions1 yearVolume of Secretions measured in ml
Assess effects of MIE on respiratory rate1 yearRespiratory rate measured by breaths per minute
Assess effects of MIE on tidal volume1 yearTidal volume measured in cubic centimeter
Assess effects of MIE on minute ventilation1 year

Secondary

MeasureTime frameDescription
Assess safety of Mechanical insufflation-exsufflation1 yearassess safety according to number of complications e.g (hypotension, arrythmias, oxygen desaturaion, pneumothorax) and number of participants with complications

Other

MeasureTime frameDescription
Compare the effects and safety of MIE versus Endotracheal Suctioning1 yearComparison accoring to number of complications with each procedure

Contacts

Primary Contacthadeer sayed khalifa
hadeer_sayed2011@yahoo.com.au01007787691
Backup Contactmaha mohamed ElKholy
maha_elkholy@yahoo.com0109656205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026