The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal discharge in patients undergoing mechanical ventilation in intensive care units
The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal secretions in patients undergoing mechanical ventilation in intensive care units
Design
The clinical trial has two intervention and control groups, with parallel, blinded, randomized
Settings and conduct
Patients in the intensive care unit of Bahonar Hospital of Kerman who were included in the study were divided into intervention and control groups by convenience sampling. Background information questionnaire was completed by patients. Nasal secretions and frequency and type of throat colonies were studied.
Participants/Inclusion and exclusion criteria
Inclusion: No infection with mouth and lungs before starting study with doctor's diagnosis
No sinusitis on arrival at diagnosis with a physician
No fractures of the face and nose
Complete occlusion of the nostril
Absence of subglottic endotracheal tube;
Exclusion: Patient transfer from ICU before completion of study
Patients with less than 10 days' hospitalization
Intervention groups
In the nasal care group, in addition to routine care, a 0.9% saline spray is sprayed in both nostrils four times a day concurrently with routine care by the nurse, and in the control group only routine care is provided by the nurse for 10 days. . Nasal discharge and pharyngeal colonization of the patient before, day 5 of intervention and day 10 of intervention are evaluated using clinical examination and sample culture.
Main outcome variables
Nasal care with 0.9% sodium chloride spray on throat colonization;
Nasal care with 0.9% sodium chloride spray on nasal secretions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170116031972N8
Registration date:2019-08-22, 1398/05/31
Registration timing:prospective
Last update:2019-08-22, 1398/05/31
Update count:0
Registration date
2019-08-22, 1398/05/31
Registrant information
Name
Mahlagha Dehghan Anari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5201
Email address
m_dehghan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal discharge in patients undergoing mechanical ventilation in intensive care units
Public title
The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal secretions in patients undergoing mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Under aggressive mechanical ventilation
Less than 12 hours have passed since the patient entered the ward
No diagnosis of oral and lung infection before starting study with physician diagnosis
No sinusitis on arrival at diagnosis with a physician
No fractures of the face and nose
Complete occlusion of the nostril
Absence of subglottic endotracheal tube
Exclusion criteria:
Transfer the patient from the ICU before completing the study
Patients with less than 10 days' hospitalization
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Available randomization, block allocation
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Ethics Committee
Street address
Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.KMU.REC.1398.220
Health conditions studied
1
Description of health condition studied
The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal secretions in patients undergoing mechanical ventilation in intensive care units
ICD-10 code
J34.8
ICD-10 code description
Other specified disorders of nose and nasal sinuses
Primary outcomes
1
Description
Effect of nasal care with 0.9% sodium chloride spray on throat colonization and nasal secretions
Timepoint
In the control group, mouthwash is administered with 0.2% chlorhexidine solution every 6 hours (4 times a day 6/12_18_24). In the intervention group (nasal care) In addition to receiving routine care, an isotonic saline spray puff (0.9%) was sprayed by the nurse simultaneously with mouthwash four times daily in both nostrils for 10 days.
Method of measurement
Background information questionnaire and nasal discharge survey and sampling of throat discharge are used for data collection.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Only routine care in the intensive care unit is provided by the nurse. In this group oral rinse with 0.2% chlorhexidine solution every 6 hours (4 times a day 6_12_18_24). Nasal secretions by a nurse who is not aware of specimens assigned to the groups and throat culture by sampling the throat secretions, before study (morning shift before routine care and intervention), end of day 5 (morning shift). Sixth day before routine care and intervention) and end of day 10 (11th morning shift before routine care).
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: In this group, in addition to the usual care, an isotonic saline spray (0.9%) was sprayed by the nurse at both nostrils four times daily for 10 days by both nostrils. The time to start the study and cultivate the first time is in the morning shift before the usual care and spraying of saline is started. And how the researcher does it correctly is explained orally. Nasal secretion type by a nurse who is not aware of the specimens assigned to the groups and throat culture by sampling the throat secretions, before the study (morning shift before routine care and intervention), end of day 5 (shift Sixth morning before routine care and intervention) and end of day 10 (11th morning shift before routine care).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital of Kerman
Full name of responsible person
Mehrnoosh eghtedarnejad
Street address
Bahonar Hospital, Gharani Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mehrnoosheghtedarnejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mehrnoosheghtedarnejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrnoosh Eghtedarnejad
Position
Masters
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mehrnoosheghtedarnejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrnoosh
Position
Masters
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mehrnoosheghtedarnejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehrnoosh Eghtedarnejad
Position
Masters
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mehrnoosheghtedarnejad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available