Effect Of Normal Saline And N-acetylcysteine On Arterial Blood Gases and vital signs During Endotracheal Suction For Mechanically Ventilation Patients : A Randomized Controlled Trials Study
1-To find out the effect of normal saline on arterial blood gases and vital signs during endotracheal suction for mechanically ventilated patients
2-To find out the effect of N-acetylcysteine on arterial blood gases and vital signs during endotracheal suction for mechanically ventilated patients
3-To find out the association between patients’ blood gases, vital signs and demographic characteristics (age, sex)
Design
Quantitative study, randomized controlled trial (RCT), used to assess the effect of normal saline and N-acetylcysteine on arterial blood gases and vital signs during endotracheal suction for mechanically patients This method is used to demonstrate the cause-and-effect relationship between the independent variable (normal saline and N-acetylcysteine) and dependent variable ( ABGs ,vital signs)
Participants will be randomly assigned to three groups (normal saline, N-acetylcysteine, control)
Settings and conduct
60 patients were on mechanically ventilation which age from 18 years admitted at the intensive care unit in Nasiriya teaching hospital and Nasiriya heart hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Male and female endotracheal tube patients between the ages of 18 and more who were thermodynamically stable and who they have an arterial cannula or ease of performing arterial blood withdrawal from the patient
Exclusion criteria
Patients instable and patients semi-conscious and Patients with specific contraindications to fluid administration
Intervention groups
When patients admitted to intensive care unit and when patient on mechanical ventilation and within the included criteria, application suction with (normal saline, N-acetylcysteine and control group). measured ABGs and vital signs before and after suction
Main outcome variables
To improve patients with mechanically ventilation after suctioning
General information
Reason for update
Acronym
ABGs
IRCT registration information
IRCT registration number:IRCT20241112063692N1
Registration date:2025-03-01, 1403/12/11
Registration timing:retrospective
Last update:2025-03-01, 1403/12/11
Update count:0
Registration date
2025-03-01, 1403/12/11
Registrant information
Name
Riam Motasher Skihy
Name of organization / entity
University of Baghdad
Country
Iraq
Phone
+964 780 222 7302
Email address
riyam.najm2302m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-01, 1403/09/11
Expected recruitment end date
2025-03-01, 1403/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Normal Saline And N-acetylcysteine On Arterial Blood Gases and vital signs During Endotracheal Suction For Mechanically Ventilation Patients : A Randomized Controlled Trials Study
Public title
Effect Of Normal Saline And N-acetylcysteine On Arterial Blood Gases and vital signs During Endotracheal Suction For Mechanically Ventilation Patients : A Randomized Controlled Trials Study
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female endotracheal tube patients between the ages of 18.
patients who were thermodynamically stable
patients who they have an arterial cannula or ease of performing arterial blood withdrawal from the patient
Exclusion criteria:
Patients instable and patients
Semi-conscious
Patients with specific contraindications to fluid administration
Age
From 18 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
In order to maintain a transparent & scientific-based randomization process, simple randomization will be used in assigning participants (individuals:endo tracheal tube patients), to treatment & control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below & equal to 3= control, over 3= treatment). No allocation concealment will be carried out.
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
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2024-11-06, 1403/08/16
Ethics committee reference number
38
Health conditions studied
1
Description of health condition studied
Adult Patients on mechanical ventilation
ICD-10 code
P0730
ICD-10 code description
Patients on mechanical ventilation
Primary outcomes
1
Description
all patients conducted in the study will be on mechanically ventilation
Timepoint
Subject who applied suction with (normal saline, N-acetylcysteine) for patients with mechanical ventilation and measured ABGs value and vital signs before and after procedure
Method of measurement
Arterial blood gases and vital signs changes
Secondary outcomes
empty
Intervention groups
1
Description
It includes 20 samples out of 60 samples that were purposive selected and included in the first intervention group which is the use of normal saline instillation in the tracheal tube when suctioning secretion from patients on mechanical ventilation this is done by giving a set of colored cards. according to the choice ,they are placed in groups , where this group is chosen by the red card the intervention method is using normal saline and dripping it into the tracheal tube for patients on mechanical ventilation and according to the criteria of suctioning .the researcher will record the patients vital signs and arterial blood gases before and immediately after the intervention group 1: It includes 20 samples out of 60 samples that were purposive selected and included in the first intervention group which is the use of normal saline instillation in the tracheal tube when suctioning secretion from patients on mechanical ventilation this is done by giving a set of colored cards . according to the choice, they are placed in groups, where this group is chosen by the red ball the intervention method is using normal saline and dripping it into the tracheal tube for patients on mechanical ventilation and according to the criteria of suctioning. the researcher will record the patients' vital signs and arterial blood gases before and immediately after the intervention
Category
N/A
2
Description
Intervention group:20 samples out of 60 samples that were purposive selected and included in the second intervention group which is the use of N- acetylcysteine instillation in the tracheal tube when suctioning secretion from patients on mechanical ventilation this is done by giving a set of colored cards. according to the choice, they are placed in groups, where this group is chosen by the green card. the intervention method is using N- acetylcysteine and dripping it into the tracheal tube for patients on mechanical ventilation and according to the criteria of suctioning. the researcher will record the patients' vital signs and arterial blood gases before and immediately after the intervention.
Category
N/A
3
Description
Control group: Twenty samples out of 60 were samples that were purposive selected and included in the control group. patients were placed in this group according to choice of a specific type of colored cards. They were placed in this group if they chose the blue card. The usual protocols for suctioning of endotracheal tube for mechanical ventilation patients applied, the researcher will record the patients' vital signs and arterial blood gases before and immediately after the intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
AlNasiriyah Heart hospital and al-Nasiriyah teaching hospital in Thi- Qar city
Full name of responsible person
Riyam Mutasher Skihy
Street address
Thi-Qar, al Rifai
City
AlNasiriyah
Postal code
10001
Phone
+964 780 222 7302
Email
riyam.najm2302m@conursing.uobaghdad.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor wissam Jabbar Qasim, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 780 222 7302
Email
riyam.najm2302m@conursing.uobaghdad.edu.iq
Grant name
no
Grant code / Reference number
no
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Riyam Mutasher Skihy
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
AlRifai
City
AlNasiryia
Province
ThiQar
Postal code
32006
Phone
+964 780 222 7302
Email
riyam.najm2302m@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Riyam Mutasher Skihy
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
AlRifai
City
AlNasiriya
Province
ThiQar
Postal code
32006
Phone
+964 780 222 7302
Email
riyam.najm2302m@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad, College of Nursing
Full name of responsible person
Riyam Mutasher Skihy
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
AlRifai
City
AlNasiryia
Province
ThiQar
Postal code
32006
Phone
+964 780 222 7302
Email
riyam.najm2302m@conursing.uobaghdad.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
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
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties
Under which criteria data/document could be used
It may be used after seeking the author's permission
From where data/document is obtainable
The author's professional e-mail that will be available
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors