Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection

Mechanical Ventilation Complication Clinical Trial

— ABSENTA  

Official title:

Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310941
• Other study ID #: ABSENTA
• Secondary ID: Pending
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: May 2024
• Source: Hospital San Carlos, Madrid
• Contact: Miguel Sánchez Garcia, MD. PhD.
• Phone: +34658762739
• Email: miguelsanchez.hcsc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU. Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes. Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like eradicating bacteria or reducing inflammation.

Description:

Open label randomized

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2026
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent
• Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
• Intubated with a cuffed endotracheal tube or tracheostomy cannula.

Exclusion Criteria:

• Frank hemoptisis
• Barotrauma (pneumothorax or pneumomediastinum)
• Bronchospasm (patients on bronchodilators for previous bronchospasm may be included)
• Suspected unmonitored intracraneal hypertension

Related Conditions & MeSH terms

• Cross Infection
• Endotracheal Intubation
• Healthcare-Associated Pneumonia
• Infections
• Mechanical Ventilation Complication
• Nosocomial Infection
• Nosocomial Pneumonia
• Pneumonia
• Respiratory Tract Infections
• Tracheobronchitis

Intervention

Device:
• Mechanical insufflation-exsufflation
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection

Other:
• Standard of Care
systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
• Hypertonic saline with hyaluronic acid
Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session

Locations

Country	Name	City	State
Spain	Hospital Vall d´Hebrón.	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Nuestra Señora de la Candelaria.	Tenerife	Las Palmas
Spain	Virgen de la Salud	Toledo
Spain	Hospital Álvaro Cunqueiro.	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17. — View Citation

Knudtzen FC, Sprehn M, Vestbo J, Johansen IS. Mechanical insufflation/exsufflation compared with standard of care in patients with pneumonia: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1077-1080. doi: 10.1097/EJA.0000000000001209. No abstract available. — View Citation

Sanchez-Garcia M, Alvarez-Gonzalez M, Domingo-Marin S, Pino-Ramirez AD, Martinez-Sagasti F, Gonzalez-Arenas P, Cardenal-Sanchez C, Velasco-Lopez E, Nunez-Reiz A. Comparison of Mechanical Insufflation-Exsufflation and Hypertonic Saline and Hyaluronic Acid — View Citation

Sanchez-Garcia M, Santos P, Rodriguez-Trigo G, Martinez-Sagasti F, Farina-Gonzalez T, Del Pino-Ramirez A, Cardenal-Sanchez C, Busto-Gonzalez B, Requesens-Solera M, Nieto-Cabrera M, Romero-Romero F, Nunez-Reiz A. Preliminary experience on the safety and tolerability of mechanical "insufflation-exsufflation" in subjects with artificial airway. Intensive Care Med Exp. 2018 Apr 3;6(1):8. doi: 10.1186/s40635-018-0173-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median SOFA score increase >2 points on day 4	Increase in organ dysfunction score from baseline to day 4 after randomization.	inclusion to day 4 after randomization
Primary	Median respiratory support-free days increase at day 28	28 minus duration in days on high-flow nasal cannula + invasive ventilation.	Inclusion to day 28 after randomization
Primary	Percentage of subjects surviving/dying day 28	crude mortality on day 28 after randomization	Inclusion to day 28 after randomization
Secondary	Subjects with bacterial eradication in respiratory samples at day 4 after randomization	Negative tests for causal microorganism in day 4 samples	Day 3 to 5 after randomization
Secondary	Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy	Negative culture and molecular test for causative bacteria in samples at end of therapy	7 and 14 days after randomization
Secondary	Median Length of ICU stay	Duration of ICU stay from admission to discharge or death	ICU admission to discharge or death in days
Secondary	Median antibiotic-free days at 28 days	28 minus days without systemic antibiotic therapy	from study inclusion to day 28