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

Sponsor

Hospital San Carlos, Madrid (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06113939

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication Stroke, Ischemic Stroke Hemorrhagic Head Trauma Cardiac Arrest Ventilator Associated Pneumonia Airway Clearance Impairment	Device: airway clearance	N/A

Detailed 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::

Control group: ceftriaxone 2 g/24 hours, 3 doses
Subglottic aspiration of secretions
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open label randomizedOpen label randomized

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care IV ceftriaxone/24 hours 3 doses	Device: airway clearance mechanical suctioning of airway secretions
Experimental: Subglottic aspiration Continuos aspiration of subglottic secretions	Device: airway clearance mechanical suctioning of airway secretions
Experimental: Cough Simulator Mechanical exsufflator	Device: airway clearance mechanical suctioning of airway secretions

Arm

Intervention/Treatment

Active Comparator: Standard of Care

IV ceftriaxone/24 hours 3 doses

Device: airway clearance

mechanical suctioning of airway secretions

Experimental: Subglottic aspiration

Continuos aspiration of subglottic secretions

Device: airway clearance

mechanical suctioning of airway secretions

Experimental: Cough Simulator

Mechanical exsufflator

Device: airway clearance

mechanical suctioning of airway secretions

Outcome Measures

Primary Outcome Measures

Incidence density of Respiratory tract infection per 1000 days of intubation [inclusion to day 14]
ventilator-associated pneumonia or tracheobronchitis
Incidence of adverse events [inclusion to day 14]
Device-related complications

Secondary Outcome Measures

Duration of Respiratory support [inclusion until ICU discharge or death]
Duration of mechanical ventilation plus high-flow nasal cannula
Systemic antibiotic use [inclusion to day 14]
Number of patients needing antibiotic therapy for respiratory tract infection and antimicrobial DDDs
Incidence and type of Bacterial resistance [14 days]
Identification of resistance bacteria in respiratory tract samples