- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04107363
Oropharyngeal Aspiration to Reduce Ventilator-Related Pneumonia
The Effect of Oropharyngeal Aspiration Before Position Change on Reducing the Incidence of Ventilator-Related Pneumonia
Ventilator-associated pneumonia (VAP) is one of the healthcare-related infections that is common in critically ill patients, prolongs hospital stay, significantly increases mortality and additional health care costs.
Microaspiration of oropharyngeal secretions the primary pathway in the formation of VAP has led researchers to focus on the detection of applications to prevent microbial colonization. Continuous or intermittent oropharyngeal aspiration, open system aspiration versus closed system aspiration, extensive oral care, oropharyngeal aspiration prior to patient positioning are some of these applications.
When the patient is turned to position, the outbreak accumulated in the oral cavity is more likely to move to the lower respiratory tract. In this study, it is assumed that aspiration of oropharyngeal secretions prior to each position change will reduce the accumulation of oral secretion in the endotracheal tube cuff and reduce aspiration of contaminated secretion and reduce the risk of developing VIP. This randomized controlled experimental study was planned to confirm the validity of this assumption.
This study was a randomized controlled experimental study designed to investigate the effect of oropharyngeal aspiration on decreasing the incidence of ventilator-associated pneumonia in patients receiving mechanical ventilation. The research was conducted between July 2015 and April 2019 in anesthesiology and reanimation intensive care unit. The study was carried out with 20 patients who underwent oropharyngeal aspiration as needed and 20 patients with oropharyngeal aspiration prior to each change of position.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over 18 years of age,
- Supported mechanical ventilation by endotracheal tube,
- ≥ 24 hours remaining connected to mechanical ventilator,
- Position can be changed every 2 hours during the day and 4 hours at night,
- Patients whose relatives were approved to participate in the study.
Exclusion Criteria:
- Pneumonia develops prior to mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
- Positive sputum culture was taken before mechanical ventilation support or within the first 48 hours following mechanical ventilation support,
- Patients with diabetes mellitus,
- Patients with contraindications for routine change of position
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group:
Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed. |
Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care). Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed. |
|
Other: Control group
The patients in the control group received routine nursing care in the unit.
(Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
|
The patients in the control group received routine nursing care in the unit.
(Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Ventilator-Related Pneumonia
Time Frame: Through study completion, about four years]
|
Clinical Pulmonary Infection Score (CPIS) was used in the diagnosis of VAP and, VAP was diagnosed in patients whose CPIS was above 6 in the evaluation.
Broncho alveolar lavage specimens were cultured for VAP agent/s.
Antibiotic susceptibility of microorganisms grown in positive cultures were investigated.
|
Through study completion, about four years]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGE.0.20.05.00/EY/739/924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventilator-associated Bacterial Pneumonia
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial PneumoniaChina
-
Melinta Therapeutics, Inc.WithdrawnHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial Pneumonia | Hospital-Acquired Pneumonia | Ventilator-Associated Pneumonia
-
Qilu Pharmaceutical Co., Ltd.RecruitingHospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial PneumoniaChina
-
Nanjing Yoko Biomedical Co., Ltd.Not yet recruitingHospital-acquired Bacterial Pneumonia (HABP) | Ventilator-associated Bacterial Pneumonia (VABP)
-
Shanghai Minhang Central HospitalRenJi Hospital; Ruijin Hospital; Shanghai Jiao Tong University School of MedicineUnknownMechanical Ventilation Complication | Ventilator-associated Bacterial PneumoniaChina
-
Venatorx Pharmaceuticals, Inc.Biomedical Advanced Research and Development AuthorityWithdrawnHospital-acquired Pneumonia | Ventilator-associated Pneumonia
-
PriCara, Unit of Ortho-McNeil, Inc.CompletedPneumonia | Ventilator-Associated Pneumonia | Bacterial Pneumonia | Infections, NosocomialUnited States, Ukraine, Argentina, India, Russian Federation, Croatia, Canada, Chile, France
-
Southeast University, ChinaRecruitingVentilator-associated Pneumonia | Multidrug Resistant Bacterial Infection | Polymyxin B | Pharmacogenomic Drug InteractionChina
-
Assistance Publique - Hôpitaux de ParisCompletedVentilator-Associated PneumoniaFrance
-
Tan Tock Seng HospitalNational University Hospital, Singapore; Singapore General Hospital; Changi General...WithdrawnBacteremia | Ventilator-associated Pneumonia | Healthcare-associated PneumoniaSingapore
Clinical Trials on Oropharyngeal aspiration before changing the position of the patient
-
Kaohsiung Medical University Chung-Ho Memorial...Not yet recruitingBronchial Hemorrhage
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedRight Ventricular Dysfunction | ARDS Due to Disease Caused by SARS Co-V-2Turkey
-
The First Hospital of Jilin UniversityRecruitingProne Position | Enteral Nutrition Feeding | ARDS (Moderate or Severe) | Intensive Care Unit (ICU) AdmissionChina
-
The Fourth Affiliated Hospital of Zhejiang University...Not yet recruitingAcute Respiratory Distress Syndrome (ARDS)
-
Gustave Roussy, Cancer Campus, Grand ParisNational Cancer Institute, FranceCompleted
-
Tung Yu-ChingChang Gung Memorial HospitalCompleted
-
Technical University of MunichCompletedSedation Problems | Breathing ComplicationsGermany
-
Ain Shams UniversityRecruiting
-
Odense University HospitalNot yet recruitingMultiple Myeloma in Relapse
-
Brigham and Women's HospitalNational Institutes of Health (NIH)CompletedSleep | Circadian Rhythm | Menstrual CycleUnited States