The effect of a designed care plan on incidence of aspiration and ventilator associated pneumonia in intubated patients hospitalized in the ICU in Ali Ebne Abitaleb Hospital, Zahedan 2016
1) Objectives: This study aimed to determine the effect of designed care plan on the incidence of aspiration and ventilator associated pneumonia in patients admitted to the ICU intubated Aliebn Abitalib Hospital in zahedan 2016. 2) Design: this is a randomized Single blind study. 3) Setting and conduct: The available sampling will be used, then patients are divided to the control or study group by random allocation. 4) Participants including major eligibility criteria: The study population included patients admitted to the ICU intubated and receiving mechanical ventilation by nasogastric tube fed and is eligible for the study. The available sampling will be used based on including criteria’s from intubated patients.5) Intervention: The control group receives routine care in the prevention of VAP and incidence of aspiration. In the intervention group, patient care in a care plan designed (which will be described below) is carried out. In patients in both groups before the intervention, MCPIS will be used and patients with VAP will excluded. In the intervention group, designed care plan to reduce the incidence of aspiration which is composed of four parts, in the intervention days (three days from the second day after intubation) will be done. The care plan has the following steps: raising the head of the bed to 30 degrees or more, the determination and management of gastric residual volume, abdominal massage, and oral care. 6) Main outcome measures (variables): Ventilator associated pneumonia, Aspirations, gastric residual volume.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072729100N1
Registration date:2016-10-15, 1395/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-15, 1395/07/24
Registrant information
Name
Parastoo Mohamadi
Name of organization / entity
Zahedan University of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 0059
Email address
mohammadi.p93@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a designed care plan on incidence of aspiration and ventilator associated pneumonia in intubated patients hospitalized in the ICU in Ali Ebne Abitaleb Hospital, Zahedan 2016
Public title
The effect of a designed care plan on incidence of aspiration and ventilator associated pneumonia in intubated patients
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria of the study were: being 16–65 years of age؛ the second day of intubation؛ the MCPIS score more than 5 or equal؛ the patient dosnt have pneumonia, ARDA, COPD؛ using only standard formulas for feeding؛ monitoring with mechanical ventilation for at least 96 h.
The patients with tracheostomy؛ abdominal wound؛ surgery؛ pregnancy and radiotherapy؛ ileus؛ diarrhea؛ and those using prokinetic agents؛ remove the NGT؛ changing the endothracheal tube were excluded from the study.
Before intervention and at the end of intervention
Method of measurement
In this study, pneumonia means the MCPIS score more than 5. The highest score is 10. If patients earn more than 5 point, the diagnosis of VAP is pretended.
2
Description
Aspirations
Timepoint
At the intervention days, before morning and evening massage
Method of measurement
In this study, the means of aspiration is the number of oral discharge PH that measures by test tapes. It measures each day before massage. The score less than 6 represents the aspiration.
3
Description
gastric residual volume
Timepoint
in intervention days, at morning and evening, before gavage
Method of measurement
it means the volume of gastric content that measure by syring before each gavage.
Secondary outcomes
1
Description
age
Timepoint
before intervention
Method of measurement
based on patient documented data.
2
Description
sex
Timepoint
before intervention
Method of measurement
according to phenotype
3
Description
history of ICU addmition
Timepoint
before intervention
Method of measurement
Patient recent hospitalization in ICU Prior to his current hospitalization
4
Description
Underlying disease
Timepoint
before intervention
Method of measurement
medical disease such as heart, renal, neurologic, gastric, and Pulmonary ecsept for COPD, ARDS, and pneumonia
5
Description
volume of nutritional solution
Timepoint
before gavage within interventional days
Method of measurement
The nutritional solution volume that is prescribed by doctors
6
Description
times of endotracheal suctioning
Timepoint
in each shift within interventional days
Method of measurement
The number of times that endotracheal suctioning can be performed by a nurse per shift
7
Description
The patient's level of consciousness
Timepoint
During the intervention days, each hour
Method of measurement
GCS score of the patient in accordance with standard scale of Glasgow is controlled by a nurse every hour.
8
Description
Level of sedation
Timepoint
in each shift within interventional days
Method of measurement
RASS is a scale score that is measured by the nurse in each shift
9
Description
The size of the endotracheal tube
Timepoint
before intervention
Method of measurement
Internal diameter of endotracheal tube
10
Description
Endotracheal tube cuff pressure
Timepoint
in each shift within interventional days
Method of measurement
Endotracheal tube cuff pressure measured by the nurse on each shift by a manometer for measurement.
Intervention groups
1
Description
In the intervention group, designed care plan to reduce the incidence of aspiration which is composed of four parts, in the intervention days (three days from the second day after intubation) will be done. The care plan has the following steps: raising the head of the bed to 30 degrees or more, the determination and management of gastric residual volume, abdominal massage, and oral care.
Category
Other
2
Description
The control group receives routine care in the prevention of VAP and incidence of aspiration.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Parastoo Mohamadi
Street address
School of Nursing and Midwifery, Mashahir Sq, Zahedan,
City
zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Hoshang Rafighdost
Street address
University of Medical Sciences, Docter Hesabi sq, Zahedan Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Parastoo Mohamadi
Position
Msn student in Critical Care Nursing
Other areas of specialty/work
Street address
Mashahir sq,
City
Zahedan
Postal code
Phone
+98 54 3343 0059
Fax
Email
mohamadi_parastoo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medicine
Full name of responsible person
Dr Fariba Yaghoubinia
Position
PhD
Other areas of specialty/work
Street address
Mashahir sq.
City
Zahedan
Postal code
Phone
+98 54 3343 0059
Fax
Email
yaghoubinia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parastoo Mohamadi
Position
Msn student in critical care nursing
Other areas of specialty/work
Street address
Mashahir sq,
City
Zahedan
Postal code
Phone
+98 54 3343 0059
Fax
Email
mohamadi_parastoo@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)