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Evaluating economically and clinically whether an automatic suction device can safely help prevent ventilator-associated pneumonia (VAP) in patients on ventilators in the neuro ICU: a randomized controlled study.

Economic and Clinical Impact of Automated Suction device on VAP prevention in Mechanically Ventilated Neurocritical Care Patients. A Randomized Controlled Non-Inferiority trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099492
Enrollment
80
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G969- Disorder of central nervous system, unspecified Health Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil Intervention6: Automated oropharyngeal and subglottic suction device (AOPS): The

Sponsors

NIMHANS
Lead Sponsor
INNACCEL Technologies Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted to Neuro critical care ICU requiring mechanical ventilation

Exclusion criteria

Exclusion criteria: Patients with tracheostomy, latex allergy, oropharyngeal bleeding or bleeding disorders, faciomaxillary or cervical spine injuries Patients admitted with primary lung pathology. Severe immune dysfunction Non provision of consent for participation in the study by self or relatives. Vulnerable populations such as patients with mental illness, physical disabilities, elderly individuals, pregnant or lactating women, patients with chronic neurological disorders and terminally ill patients will be excluded from study.

Design outcomes

Primary

MeasureTime frame
To compare the average per day total direct costs of ICU stay between automated and manual suction strategies.Timepoint: Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome and clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first.

Secondary

MeasureTime frame
To compare the economic burden of equipment,consumable, drugs,investigations,human resource utilization between the two groups during ICU stay, under the following headers: 1.Medications 2.Diagnostic Investigations (Cultures, Imaging) 3.Intervention charges (Surgical, Radiology) 4.Consumables (RT, ET tube, foleys, arterial line, IV cannula, central line, Suction bottle, Tubing s, AOPS consumables) 5.ICU Stay,ICU bed, Ventilator, AOPS device, Monitoring (Multiparameter monitor, EEG, TCD, arterial, ICP, Ultrasound) 6.ICU Stay & Admission charges 7.Human resources (Doctor, Nursing, Physiotherapy, Dietician etc)Timepoint: Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first.;To compare the duration of mechanical ventilation between AOPS & standard care groupsTimepoint: Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first.;To quantify antibiotic consumption in patients managed between automated & manual suction strategies.Timepoint: Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical variables will be assessed once daily (Day 1 onwards) throughout the ICU stay. Final assessment will occur at ICU discharge, death, or study withdrawal, whichever occurs first.;To evaluate the impact on the need for reserve antibiotics & escalation/de-escalation patterns between two groups.Timepoint: Patients will be included at baseline (Day 0), defined as ICU admission following surgery or intervention. Outcome & clinical

Countries

India

Contacts

Public ContactManisha J

NIMHANS

dhritiman.ch@gmail.com8197781240

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026