Effectiveness of Oropharyngeal Suctioning in Preventing Ventilator-Associated Pneumonia: A Randomized Controlled Trial.

NCT07128537 | Not Yet Recruiting

• 1 other identifier: University of Health science
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ventilator-Associated Pneumonia (VAP) is a serious infection that affects patients who are on mechanical ventilation in intensive care units (ICUs). It can increase the risk of death, prolong hospital stays, and lead to higher healthcare costs. This study is designed to evaluate the effectiveness of scheduled oropharyngeal suctioning (removal of secretions from the mouth and throat) every 4 hours in preventing early-onset VAP in ICU patients who require mechanical ventilation for more than 48 hours. The study will compare two groups of ICU patients: one group will receive scheduled oropharyngeal suctioning every 4 hours in addition to standard oral care, while the other group will receive only standard oral care. The main goal of the study is to determine whether regular suctioning reduces the incidence of VAP, improves patient recovery, and shortens the duration of mechanical ventilation. This research will help clarify whether adding scheduled suctioning to standard care can prevent VAP and improve clinical outcomes for critically ill patients, potentially leading to better practices in ICU care.

Conditions

Ventilation Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• incidence of early-onset Ventilator-Associated Pneumonia (VAP) in mechanically ventilated ICU patients.

  VAP will be diagnosed using the Modified Clinical Pulmonary Infection Score (MCPIS), which evaluates clinical indicators such as body temperature, pulmonary secretions, white blood cell count, the PaO2/FiO2 ratio, and chest radiography findings. A score of ≥6 on the MCPIS indicates the presence of VAP. This primary outcome will help determine whether the intervention (scheduled oropharyngeal suctioning every 4 hours) significantly reduces the incidence of VAP compared to standard oral care practices in ICU patients.

  The primary outcome measure, incidence of early-onset VAP, will be assessed from Day 1 to Day 5 of mechanical ventilation in the ICU, specifically during the period of scheduled oropharyngeal suctioning intervention.

Study Arms (2)

Standard Oral Care (Twice-Daily Brushing)

ACTIVE COMPARATOR

Participants in this group will receive standard oral care as part of ICU routine practice. This includes brushing of teeth, gums, and tongue twice a day to clear accumulated secretions and reduce bacterial growth. Additionally, on-demand suctioning will be performed if clinically indicated (e.g., when visible secretions or discomfort are observed). The control group will not receive the scheduled 4-hourly suctioning intervention, serving as a comparison to evaluate the effectiveness of regular suctioning in preventing VAP.

Procedure: Standard Oral Care (Twice-Daily Brushing)

Participants in this group will receive scheduled oropharyngeal suctioning every 4 hours, in additio

EXPERIMENTAL

Participants in this group will receive scheduled oropharyngeal suctioning every 4 hours, in addition to routine oral care (twice-daily brushing of teeth, gums, and tongue). The oropharyngeal suctioning involves the mechanical removal of secretions from the oral cavity and pharynx using a sterile suction catheter to prevent bacterial buildup and aspiration into the lungs. This intervention is intended to reduce the risk of early-onset Ventilator-Associated Pneumonia (VAP) by continuously clearing harmful secretions from the airway.

Procedure: Scheduled Oropharyngeal Suctioning Every 4 Hours

Interventions

Scheduled Oropharyngeal Suctioning Every 4 Hours PROCEDURE

The intervention in this study involves scheduled oropharyngeal suctioning every 4 hours, which distinguishes it from other oral care protocols used in clinical practice. In this arm, patients will receive systematic suctioning of the oropharyngeal area using a sterile suction catheter every 4 hours throughout their ICU stay, starting from the first day of mechanical ventilation. This frequent suctioning is designed to remove accumulated secretions that can harbor bacteria, reducing the risk of aspiration into the lungs, which is a major cause of early-onset Ventilator-Associated Pneumonia (VAP). This intervention is not based on clinical need or visible signs of discomfort (as with traditional on-demand suctioning). Instead, it follows a standardized protocol of proactive, scheduled suctioning. The procedure will be performed by trained ICU staff and will involve suctioning for 10-15 seconds per session, ensuring adequate removal of secretions while minimizing patient discomfort. In

Participants in this group will receive scheduled oropharyngeal suctioning every 4 hours, in additio

Standard Oral Care (Twice-Daily Brushing) PROCEDURE

Participants in this group will receive standard oral care as part of ICU routine practice. This includes brushing of teeth, gums, and tongue twice a day to clear accumulated secretions and reduce bacterial growth. Additionally, on-demand suctioning will be performed if clinically indicated (e.g., when visible secretions or discomfort are observed). The control group will not receive the scheduled 4-hourly suctioning intervention, serving as a comparison to evaluate the effectiveness of regular suctioning in preventing VAP.

Standard Oral Care (Twice-Daily Brushing)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU patients aged 18-75 years.
• Patients expected to require invasive mechanical ventilation for more than 48 hours.
• Modified Clinical Pulmonary Infection Score (MCPIS) ≤ 5 on Day 1, indicating no or minimal signs of infection.
• Ability to comply with the study protocol, including informed consent from patient attendants.

You may not qualify if:

• Patients with chronic respiratory diseases (e.g., COPD, asthma).
• Immunocompromised patients (e.g., those with cancer, organ transplant recipients, or on immunosuppressive therapy).
• Patients with ongoing sepsis or severe infections at the time of enrollment.
• Patients who have been on mechanical ventilation for more than 48 hours at the time of ICU admission.
• Pregnant patients or those unable to comply with the study protocol.
• Patients with dental prosthetics or dentures, as these may interfere with the suctioning process.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Central Study Contacts

Prof. Samina Kausar professor of nursing

CONTACT

03334072790; saminamanzoor52@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a randomized controlled trial (RCT) designed to evaluate the effectiveness of scheduled oropharyngeal suctioning every 4 hours in reducing the incidence of early-onset ventilator-associated pneumonia (VAP) in mechanically ventilated ICU patients. An RCT is the gold standard in clinical research as it helps establish cause-and-effect relationships between an intervention and an outcome.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start: September 10, 2025
• Primary Completion: November 10, 2025
• Study Completion: December 10, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08