Oropharyngeal Aspiration to Reduce Ventilator-Related Pneumonia

Sponsor
Ayşe AKBIYIK (Other)
Overall Status
Completed
CT.gov ID
NCT04107363
Collaborator
(none)
40
2
48

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Oropharyngeal aspiration before changing the position of the patient
  • Other: Control group:
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Oropharyngeal Aspiration Before Position Change on Reducing the Incidence of Ventilator-Related Pneumonia
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

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.

Procedure: Oropharyngeal aspiration before changing the position of the patient
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).

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).

Outcome Measures

Primary Outcome Measures

  1. Incidence of Ventilator-Related Pneumonia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ayşe AKBIYIK

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ayşe AKBIYIK, Doctor of Philosophy (PhD) Research Assistant, Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT04107363
Other Study ID Numbers:
  • EGE.0.20.05.00/EY/739/924
First Posted:
Sep 27, 2019
Last Update Posted:
Sep 27, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2019