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

NCT ID: NCT06113939

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-12-20

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.

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::

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

IV ceftriaxone/24 hours 3 doses

Group Type: ACTIVE_COMPARATOR

airway clearance

Intervention Type: DEVICE

mechanical suctioning of airway secretions

Subglottic aspiration

Continuos aspiration of subglottic secretions

Group Type: EXPERIMENTAL

airway clearance

Intervention Type: DEVICE

mechanical suctioning of airway secretions

Cough Simulator

Mechanical exsufflator

Group Type: EXPERIMENTAL

airway clearance

Intervention Type: DEVICE

mechanical suctioning of airway secretions

Interventions

airway clearance

mechanical suctioning of airway secretions

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Miguel Sanchez Garcia

Director Critical Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Alvarez-Gonzalez, MD.PhD

Role: STUDY_DIRECTOR

Hospial Clinico San Carlos

Sandra Garcia Pintado, RN

Role: PRINCIPAL_INVESTIGATOR

Hospial Clinico San Carlos

Locations

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Countries

Spain

Central Contacts

Miguel Sánchez Garcia, MD. PhD.

Role: CONTACT

miguelsanchez.hcsc@gmail.com

+34658762739

Belén belenhhernanz@gmail.com, PhD

Role: CONTACT

+34658762739

Other Identifiers

PIRAMIDES

Identifier Type: -

Identifier Source: org_study_id