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Ventilation Acquired PneumoniaNCT07128537

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

A study testing Scheduled Oropharyngeal Suctioning Every 4 Hours and Standard Oral Care (Twice-Daily Brushing) in people with Ventilation Acquired Pneumonia, run by University of Health Sciences Lahore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ventilation Acquired Pneumonia
What is being tested?
Scheduled Oropharyngeal Suctioning Every 4 Hours and Standard Oral Care (Twice-Daily Brushing)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
10 Sep 2025to 10 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Prof. Samina Kausar professor of nursing contact

03334072790

saminamanzoor52@yahoo.com

About this study

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.

Read the 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.

Being tested
Scheduled Oropharyngeal Suctioning Every 4 Hours, Standard Oral Care (Twice-Daily Brushing)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scheduled Oropharyngeal Suctioning Every 4 HoursProcedure or surgery

    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

  • Standard Oral Care (Twice-Daily Brushing)Procedure or surgery

    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.

Study groups in NCT07128537
Study groupRoleWhat they receive
Standard Oral Care (Twice-Daily Brushing)Active comparatorParticipants 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.
Receives: Procedure: Standard Oral Care (Twice-Daily Brushing)
Participants in this group will receive scheduled oropharyngeal suctioning every 4 hours, in additioExperimentalParticipants 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.
Receives: Procedure: Scheduled Oropharyngeal Suctioning Every 4 Hours

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start10 Sep 2025 (estimated)
  3. Primary completion10 Nov 2025 (estimated)
  4. Study completion10 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07128537
Sponsor's protocol ID
University of Health science
Status last verified
Aug 2025
First submitted
13 Aug 2025
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Scheduled Oropharyngeal Suctioning Every 4 Hours and Standard Oral Care (Twice-Daily Brushing) in people with Ventilation Acquired Pneumonia, run by University of Health Sciences Lahore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prof. Samina Kausar professor of nursing (03334072790, saminamanzoor52@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of early-onset Ventilator-Associated Pneumonia (VAP) in mechanically ventilated ICU patients. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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