Prevention of Infection of the Respiratory Tract Through Application of Non-Invasive Methods of Secretion Suctioning

Cardiac Arrest Clinical Trial

— PIRAMIDES  

Official title:

A Randomized Controlled Pilot Trial Comparing 2 Non-invasive Airway Clearance Methods for the Prevention of Early-onset Ventilator-associated Pneumonia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113939
• Other study ID #: PIRAMIDES
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

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

Severe trauma, head trauma, stroke and resuscitated cardiac arrest patients requiring endotracheal intubation and mechanical ventilation are at high risk of early-onset ventilator-associated pneumonia (EO-VAP). A short course of systemic antibiotic is recommended for prophylaxis.

This study intends to assess the safety and efficacy of 2 alternative mechanical non-invasive airway clearance techniques in the prevention of EO-VAP in an open label randomized pilot trial of 20 subjects per study group i.e., 60 cases. The interventions will be in place for 7 days and the observational periods will be 14 days.

Description:

Background. Patients with structural coma are at high risk of so-called early onset pneumonia (EOP). Incidence rates of up to 50% have been reported in patients with head trauma or stroke. The usual causative microorganisms belong to the normal upper airway flora like Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenza and Moraxella catarrhalis. EOP typically is not present at admission and develops after 2 to 7 days after endotracheal intubation.

A short course of systemic antibiotic therapy and aspiration of subglottic secretions (ASS) are associated with significant reductions in EOP, although ASS does not prevent late-onset pneumonia. Non-invasive mechanical methods may avoid the use of prophylactic antibiotics and pain and injury to the tracheal mucosa caused by the conventional suctioning catheter.

The primary objectives of the present randomized pilot trial is to compare the prevention of respiratory tract infections during invasive mechanical ventilation and occurrence of device-associated adverse events of non-invasive mechanical airway clearance devices with standard of care in the ICU Department at Hospital Clinico San Carlos.

Secondary objectives are duration of intubation and respiratory support (mechanical intubation plus high flow nasal cannula).

Methods. Informed consent will be requested from relatives in patients admitted to intensive care (Neuro-trauma unit) requiring endotracheal intubation estimated to last >48 hours, who do not have a hopeless prognosis.

Closed envelopes will be used for allocation to one of the 3 study groups::

1. Control group: ceftriaxone 2 g/24 hours, 3 doses

2. Subglottic aspiration of secretions

3. Cough simulator

Patients in all groups will receive the topical components of selective decontamination of the digestive tract (SDD) while intubated.

In groups 2 and 3 the allocated study group prevention intervention will be applied during the first 7 days.

The main study objectives will be monitored over the first 14 days of intubation or until extubation if performed before day 14.

Sample size will be 60 subjects, 20 per study group, enrolled in blocs of 5, with the 5th case of each bloc being allocated in random sequence.

Nurses will be trained in using the devices for groups 2 and 3 before the start of enrollment phase.

The diagnosis of pneumonia vs tracheobronchitis will be based on chest x-ray and confirmed by lung ultrasound to exclude chest x-ray false negatives.

On day 5 to 7 or immediately before extubation, if planned earlier, electrical impedance tomography will be performed to compare lung air distribution and compliance between groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Endotracheal intubation anticipated to last >48 hours

• Stroke

• Severe Trauma

• Head Trauma

• Resuscitated cardiac arrest

Exclusion Criteria:

• Ominous prognosis

• Limitation of Life support

Related Conditions & MeSH terms

• Airway Clearance Impairment
• Cardiac Arrest
• Craniocerebral Trauma
• Head Trauma
• Hemorrhagic Stroke
• Intubation Complication
• Ischemic Stroke
• Pneumonia
• Pneumonia, Ventilator-Associated
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic
• Ventilator Associated Pneumonia

Intervention

Device:
• airway clearance
mechanical suctioning of airway secretions

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence density of Respiratory tract infection per 1000 days of intubation	ventilator-associated pneumonia or tracheobronchitis	inclusion to day 14
Primary	Incidence of adverse events	Device-related complications	inclusion to day 14
Secondary	Duration of Respiratory support	Duration of mechanical ventilation plus high-flow nasal cannula	inclusion until ICU discharge or death
Secondary	Systemic antibiotic use	Number of patients needing antibiotic therapy for respiratory tract infection and antimicrobial DDDs	inclusion to day 14
Secondary	Incidence and type of Bacterial resistance	Identification of resistance bacteria in respiratory tract samples	14 days