To determine the Effectiveness of Using Mouth Moisturizing Spray on the Outcomes of Cardiac Surgery Patients following Endotracheal Extubation
Design
Quasi-experimental with control group
Settings and conduct
The samples will be selected from patients undergoing heart surgery in selected hospitals of Shahid Beheshti University of Medical Sciences. Due to the nature of the study, blinding is only possible for the data analyst.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Over 18 years old; 2. being literate in reading and writing; 3. Aware of time, place and person. 4. Extubation of the patient after consciousness. 5. A patient undergoing coronary artery bypass surgery or valve replacement with the help of a pump.
Exclusion:
1. History of neuromuscular disease (such as stroke, parkinsonism) or head and neck abnormalities. 2. Have a swallowing problem before. 3. Tracheostomy. 4. Inability to respond linguistically. 5. Cardiopulmonary resuscitation of the patient during and after the operation.
Intervention groups
Control: Routine care
Intervention: A safety protocol will be implemented by the researcher. The intervention group will recieve comprehensive oral care, including routine cleaning and moisturizing. A water spray will be given to them in the mouth and pharynx every 30 minutes (up to 4 hours post-extubation). The patient will be instructed to swallow after each spray.
Main outcome variables
Thirst, nausea, vomiting and dysphagia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240408061453N1
Registration date:2024-05-26, 1403/03/06
Registration timing:registered_while_recruiting
Last update:2024-05-26, 1403/03/06
Update count:0
Registration date
2024-05-26, 1403/03/06
Registrant information
Name
Akbar Zare-Kaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 699 0935
Email address
akbar.zarekaseb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Using Mouth Moisturizing Spray on the Outcomes of Cardiac Surgery Patients following Endotracheal Extubation
Public title
The effect of oral moisturizing spray on extubation outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
being literate in reading and writing
Aware of time, place, and person
Extubation of the patient after consciousness
A patient undergoing coronary artery bypass surgery or valve replacement on pump.
Exclusion criteria:
History of neuromuscular disease (such as stroke, parkinsonism) or head and neck abnormalities.
Have a swallowing problem before.
Tracheostomy.
Inability to respond verbally.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After surgery, an independent research assistant, who will not be involved in data collection, used the Research Randomizer software (http://www.randomizer.org) to prepare a list of random numbers with fifty-five sets of numbers (numbers 1 and 2). 1 and 2 representing the intervention group and the control group, respectively. The numbers will be printed separately and each will be sealed in an envelope so that only the research assistant will know the information inside each envelope. The envelopes will be placed in a box. Then the researcher will open the envelopes in order. Therefore, eligible participants will be randomly assigned to one of two intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, it is not possible to blind the researcher and the patient, however, the person who is in charge of data analysis will be completely blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculties of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of Medical Sciences (Resea
Street address
Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۷۴۴۳
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.010
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Thirst
Timepoint
Thirst evaluation will be done before the intervention, immediately after the first intervention, 2 and 4 hours after the intervention.
Method of measurement
10-point numerical rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: After the tube is removed, oral intake will begin 6 hours after the tube is removed. Critical care nurses will provide routine care, including moisturizing the mouth of patients who complain of thirst. When participants show no signs of gagging/coughing on a small amount of water, the patient will be given a small, consistent amount of food/fluid that is tolerated.
Category
Treatment - Other
2
Description
Intervention group: Before the intervention, the researcher will use a safety protocol for post-operative thirst management that measures three aspects: level of consciousness, airway, and nausea and vomiting. After completing the evaluation immediately after the removal of the endotracheal tube or when a change in the patient's condition was observed, the intervention group received a comprehensive oral care program including routine oral care for cleanliness after the removal of the tracheal tube, moisturizing the mouth with Vaseline. They will receive a water spray in the mouth and pharynx twice an hour (up to 4 hours after the endotracheal tube is removed). Water is sprayed in all parts of the oral cavity, including the right and left cheek, upper and lower jaw, and the entire surface of the tongue. After each spray, the patient will be instructed to complete the act of swallowing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Akbar Zare-Kaseb
Street address
Imam Hossein Square, Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 938 699 0935
Email
akbar.zarekaseb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Velenjak, Arabi Ave
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 21 2243 9770
Email
zarghi@sbmu.ac.ir
Grant name
Research Committee of Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Akbar Zare-Kaseb
Position
Master`s student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 938 699 0935
Email
akbar.zarekaseb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Akbar Zare-Kaseb
Position
Master`s student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 938 699 0935
Email
akbar.zarekaseb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Akbar Zare-Kaseb
Position
Master`s student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vali-e-Asr St.
City
Tehran
Province
Tehran
Postal code
1434743397
Phone
+98 938 699 0935
Email
akbar.zarekaseb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Participants data file
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data will be made available upon request for secondary studies.
From where data/document is obtainable
Responsible author of the article
What processes are involved for a request to access data/document