NCT03940118

Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline

A Randomized Study on the Safety and Tolerability of Mechanical Insufflation-exsufflation and Hypertonic Saline With Hyaluronic Acid for Suctioning of Respiratory Tract Secretions in Patients With Artificial Airway

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Conventional catheter suctioning of respiratory tract secretions is a mandatory procedure in intubated patients. Poor tolerance, pain and other, sometimes severe, lung and cardiovascular complications may occur during suctioning. Mechanical insufflation-exsufflation (MIE), coupled with hypertonic saline (HS), may improve efficacy airway clearance and reduce risk of the maneuver. However, safety of MIE and HS in intubated patients have not been studied appropriately, which justifies a randomized evaluation compared to conventional secretion suctioning.

Detailed description

Secretion suctioning (SS) in patients with artificial airway is a mandatory procedure, although occasionally painful, not tolerated and even causing traumatic injury to the respiratory mucosa. Mechanical insufflation-exsufflation (MIE) and nebulized hypertonic saline with hyaluronic acid (HS-HA) have shown efficacy and safety in patients with chronic neuromuscular and pulmonary diseases, achieving aspiration and fluidification of respiratory secretions, respectively, as well as good tolerance. Only anecdotal experience about the safety of MIE and HS-HA in critically ill patients with artificial airway and mechanical ventilation is available. Background: Both MIE and HS-HA facilitate the drainage of secretions from the distal airway (compared to conventional catheter suctioning, the effect of which is supposed to be limited to the trachea) Both measures may prove to be efficacious in the prevention (through airway clearance of secretions) and concomitant treatment (reduction of inoculum or "draining the lung") of lower respiratory tract infections (tracheobronchitis and pneumonia).

Conditions

• Endotracheal Tube
• Tracheostomy

Interventions

Type	Name	Description
DEVICE	Catheter secretion suctioning	Catheter secretion suctioning with prior nebulization of hypertonic saline
COMBINATION_PRODUCT	Secretion suctioning + hypertonic saline	Catheter secretion suctioning with prior nebulization of hypertonic saline
DEVICE	Ins-exsufflation	Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
COMBINATION_PRODUCT	Ins-exsufflation + Hypertonic saline	Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2019-05-07
• Last updated: 2019-05-08

Locations

1 site across 1 country: Spain