Effect of intermittent subglottic secretions drainage combined with closed endotracheal suctioning in comparison with open endotracheal suctioning on incidence of ventilator associated pneumonia in intubated patients in Al-Zahra hospital intensive care units,Isfahan University of Medical Sciences.
Objective: effect of intermittent subglottic secretions drainage combined with closed endotracheal suctioning on incidence of ventilator associated pneumonia in critical care units at Alzahra hospital, Isfahan, Iran in 2012. Study Design: randomized clinical trial. Study population: patients admitted to intensive care units of Alzahra hospital at Isfahan. Inclusion criteria: willingness to participate in the study; patients 18 to 60 years, intubation within 24 past hours, absence of pneumonia before intubation. Exclusion criteria: death before end of study, surgery in period of study. Intervention: in the intervention group subglottic secretions drainage, with use of inspiratory pause key that embedded in mechanical ventilator and endotracheal suctioning with closed endotracheal suctioning system was performed. Time of intervention: interventions were performed for 5 days after intubation. Ventilator-associated pneumonia-related variables, including body temperature, white blood cell count, assessment for purulent secretions, the ratio of arterial oxygen pressure to inspiratory oxygen fraction and infiltration on chest radiography of the patients, within 5 days in both groups were performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042913179N1
Registration date:2013-08-04, 1392/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Rahimeh Safdari
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 19 3082 3767
Email address
safdari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2012-11-15, 1391/08/25
Expected recruitment end date
2013-02-13, 1391/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intermittent subglottic secretions drainage combined with closed endotracheal suctioning in comparison with open endotracheal suctioning on incidence of ventilator associated pneumonia in intubated patients in Al-Zahra hospital intensive care units,Isfahan University of Medical Sciences.
Public title
prevention of ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Patients 18 to 60 years, mechanical ventilation more than 48 hr,free of pneumonia before intubation,
exclusion criteria:death before 48 hr, extubation before end of study, surgery during the study period.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Drainage of secretions around the endotracheal tube cuff was performed with inspiratory pause maneuver. The patient was blinded to intervention due to the anesthesia. Infectious disease specialist who was responsible for determining ventilator-associated pneumonia was blind to the grouping. the researcher were aware of the grouping.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Isfahan university of medical science.
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib,Isfahan Isfahan Isfahan Iran, Islamic Republic Of 461-81746
City
Isfahan
Postal code
8174673548
Approval date
2012-10-28, 1391/08/07
Ethics committee reference number
391295
Health conditions studied
1
Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J95.9
ICD-10 code description
Postprocedural respiratory disorder, unspecified
Primary outcomes
1
Description
Incidence of Ventilator Associated Pneumonia
Timepoint
Before intubation, day 1, day 2, day 3, day 4, day 5,
Method of measurement
Clinical Pulmonary Infection Score, CPIS.
Secondary outcomes
empty
Intervention groups
1
Description
Interventions in the Intervention group consist of closed suction system, 72-hour for endotracheal suctioning and subglottic secretions drainage. Every 3 hour, after oral full suction, the cuff of the endotracheal tube was connected to a cuff pressure gauge manometer. Inspiratory hold with use of inspiratory pause key that embedded in ventilator was performed. This key can hold breathing for 7 seconds and hyperinflated the lungs, in 3 seconds of holding the key, endotracheal tube cuff was depleted and pressure of air that trapping in the lungs, causing secretions to be pushed into the oral cavity. Tracheal tube cuff inflated in 6th second and the pressure was adjusted between 25 and 30 cm H2O. Oral cavity was cleaned with frequent suctioning. This maneuver was applied every three hours and immediately before the closed suction. For a closed suction, a suction catheter package that is used for 72hr was used. After identifying that the patient needs to be suctioned, Suction was attached to the suction connector and negative pressure was set to 200 cm H2O. Catheter sent into the patient's airway and after suction, catheter was removed.
Category
Prevention
2
Description
In the control group, open suctioning was performed in sterile method, and subglottic secretions drainage was not performed.