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

NCT ID: NCT07128537

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2025-12-10

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.

Detailed Description

Ventilator-Associated Pneumonia (VAP) is a major healthcare concern in intensive care units (ICUs), affecting patients who require mechanical ventilation. VAP typically develops more than 48 hours after intubation and is caused by the aspiration of contaminated oropharyngeal secretions into the lungs. This infection is associated with increased morbidity, prolonged ICU stays, and higher mortality rates. The incidence of early-onset VAP (developing within the first 4-5 days of ventilation) is particularly concerning due to its association with more virulent pathogens and higher mortality rates. Despite the implementation of preventive measures, early-onset VAP continues to be a significant clinical challenge, necessitating the exploration of more effective interventions.

The primary aim of this study is to assess the effectiveness of scheduled oropharyngeal suctioning every 4 hours in preventing early-onset VAP in mechanically ventilated ICU patients. Oropharyngeal suctioning, which involves the mechanical removal of secretions from the mouth and throat, is a standard procedure in many ICUs to maintain airway patency. However, its role in preventing VAP, especially when performed at fixed intervals, has not been conclusively established. While previous studies have suggested that oropharyngeal suctioning may reduce VAP risk, the optimal frequency and protocol remain unclear.

This study will be conducted as a randomized controlled trial (RCT) at the Institute of Nursing, University of Health Sciences, Lahore, in collaboration with Jinnah Hospital, Lahore. The study will include 100 ICU patients who are expected to be mechanically ventilated for more than 48 hours. The patients will be randomly assigned to two groups:

Intervention Group: Scheduled oropharyngeal suctioning every 4 hours, in addition to routine oral care.

Control Group: Standard oral care, including twice-daily brushing of teeth, gums, and tongue, and on-demand suctioning based on clinical indications.

The study's primary outcome will be the incidence of early-onset VAP, diagnosed using the Modified Clinical Pulmonary Infection Score (MCPIS), a tool widely used in ICUs to diagnose VAP based on clinical symptoms, microbiological findings, and radiographic evidence. Secondary outcomes will include the duration of mechanical ventilation, ICU length of stay, and patient mortality rates.

The study will also assess the effect of the intervention on various factors, including the rate of microbial colonization in the oropharyngeal area, the impact on bacterial load, and the overall health outcomes of ICU patients. By systematically evaluating the role of scheduled oropharyngeal suctioning, the study aims to provide valuable insights into its potential benefits as part of a broader VAP prevention strategy.

The data collection process will be divided into two phases:

Phase 1 (Day 1): Collection of demographic data, baseline MCPIS score, and other clinical variables.

Phase 2 (Day 5): Follow-up to assess the presence or absence of VAP, the length of ICU stay, the duration of mechanical ventilation, and patient mortality.

Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 24. Descriptive statistics will be used to summarize the data, and chi-square or Fisher's Exact Test will be used to compare the incidence of VAP between the two groups. The duration of mechanical ventilation and ICU stay will be analyzed using t-tests or Mann-Whitney U tests, depending on data distribution. A p-value of ≤ 0.05 will be considered statistically significant.

The study will also explore whether the frequency of oropharyngeal suctioning (every 4 hours vs. as needed) is associated with improvements in other clinical outcomes, including reductions in the duration of mechanical ventilation and the length of ICU stay, which would further demonstrate the potential benefits of this intervention in ICU settings.

In addition to its clinical impact, this study aims to contribute to the development of standardized, evidence-based guidelines for oropharyngeal suctioning in ICUs worldwide, potentially leading to improved VAP prevention protocols. If the findings suggest that scheduled oropharyngeal suctioning is effective in preventing VAP, the results could inform clinical practice and guide the development of best practices for oral care in critically ill patients.

The results of this study are expected to have a significant impact on ICU practices, improving patient safety, reducing the incidence of VAP, and lowering healthcare costs associated with VAP-related complications. Moreover, the study could serve as a foundation for future research into oral care interventions and VAP prevention strategies in mechanically ventilated patients.

Conditions

Ventilation Acquired Pneumonia

Study Design

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

Study Groups

Standard Oral Care (Twice-Daily Brushing)

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.

Group Type: ACTIVE_COMPARATOR

Standard Oral Care (Twice-Daily Brushing)

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

Scheduled Oropharyngeal Suctioning Every 4 Hours

Intervention Type: 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

Interventions

Scheduled Oropharyngeal Suctioning Every 4 Hours

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

Intervention Type: PROCEDURE

Standard Oral Care (Twice-Daily Brushing)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Hafiz Abdul Wajid

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Prof. Samina Kausar professor of nursing

Role: CONTACT

saminamanzoor52@yahoo.com

03334072790

Other Identifiers

University of Health science

Identifier Type: -

Identifier Source: org_study_id