Safety of Mechanical Insufflation-exsufflation and Hypertonic Saline (SMASH)

San Carlos Clinical Hospital

Status: Completed

Conditions: Endotracheal Tube; Tracheostomy

Treatments: Device: Catheter secretion suctioning; Combination Product: Secretion suctioning + hypertonic saline; Combination Product: Ins-exsufflation + Hypertonic saline; Device: Ins-exsufflation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03940118

18/253-R_X

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Artificial airway ( endotracheal tube or tracheostomy cannula) with pressure cuff.
• Need for aspiration of secretions
• Informed consent

Exclusion criteria

• Macroscopic hemoptysis.
• Acute bronchospasm
• Uncrontrolled muscular contractions, like tremor, myoclonus or other.
• Confirmed pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Catheter secretion suctioning

Active Comparator group

Description:

Secretions are aspirated with a catheter at -120 to -150 mBar

Treatment:

Device: Catheter secretion suctioning

Secretion suctioning + hypertonic saline

Experimental group

Description:

Hypertonic saline is nebulized prior to aspiration of secretions.

Treatment:

Combination Product: Secretion suctioning + hypertonic saline

Ins-exsufflation

Experimental group

Description:

Mechanical insufflation-exsufflation with device programmed at 50/-50 mmHg

Treatment:

Device: Ins-exsufflation

Ins-exsufflation + Hypertonic Saline

Experimental group

Description:

Mechanical insufflation-exsufflation and hypertonic saline

Treatment:

Combination Product: Ins-exsufflation + Hypertonic saline