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Protocol summary
I.To determine the effect preoperative use of an Incentive Spirometer has on preventing postoperative pulmonary complications among cardiac surgical patients.
III.To determine the socio-demographic and clinical factors associated with increased risk for the development of postoperative pulmonary complications following cardiac surgeries.
I.To determine the effect preoperative use of an Incentive Spirometer has on preventing postoperative pulmonary complications among cardiac surgical patients.
III.To determine the demographic and clinical factors associated with increased risk for the development of postoperative pulmonary complications following cardiac surgeries.
I.To determine the effect preoperative use of an Incentive Spirometer has on preventing postoperative pulmonary complications among cardiac surgical patients. III.To determine the socio-demographic and clinical factors associated with increased risk for the development of postoperative pulmonary complications following cardiac surgeries.
Inclusion criteria:
Patients who will agree to participate in the study based on their informed consent.
Subjects with age >50 years.
Patients who undergo open heart surgery including ( coronary and valvular) procedures
Exclusion criteria:
Patients who refuse to participate in the study
thoracic, abdominal, or cerebral aneurysms
Recent cardiothoracic or abdominal surgery.
Inclusion criteria:
Patients who will agree to participate in the study based on their informed consent.
Patients who undergo open heart surgery including ( coronary and valvular) procedures
Exclusion criteria:
thoracic, abdominal, or cerebral aneurysms
Recent cardiothoracic or abdominal surgery.
Inclusion criteria: Patients who will agree to participate in the study based on their informed consent. Subjects with age >50 years. Patients who undergo open heart surgery including ( coronary and valvular) procedures Exclusion criteria: Patients who refuse to participate in the study thoracic, abdominal, or cerebral aneurysms Recent cardiothoracic or abdominal surgery.
Protocol summary
Study aim
I.To determine the effect preoperative use of an Incentive Spirometer has on preventing postoperative pulmonary complications among cardiac surgical patients.
III.To determine the demographic and clinical factors associated with increased risk for the development of postoperative pulmonary complications following cardiac surgeries.
Design
Interventional, prospective, randomized
Settings and conduct
The study will be conducted in three centers in the city of Baghdad, including Ibn Al-Nafees Cardiology Hospital, Iraqi center for heart diseases, Ibn Al-Bitar center for cardiac surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who will agree to participate in the study based on their informed consent.
Patients who undergo open heart surgery including ( coronary and valvular) procedures
Exclusion criteria:
thoracic, abdominal, or cerebral aneurysms
Recent cardiothoracic or abdominal surgery.
Intervention groups
Patients allocated to the intervention group were trained to use the IS, they were asked to maintain sitting position, hold the IS in an upright position, place the lips tightly around the mouthpiece and perform slow and deep inhalation in order to raise the balls in the chambers one by one gradually to set the target of 1.200 cc. At maximum inhalation, the mouthpiece is removed, followed by a breath-hold and normal exhalation. Patients were asked to repeat the maneuver in a set of ten times hourly while awake until the day of the surgical operation.
Main outcome variables
Primary outcomes:
The incidence of postoperative pulmonary complications, which are scored by a pulmonologist who is blinded to patients’ allocation
General information
Reason for update
The reason for update is to edit some information regarding the sample age , inclusion criteria and recruitment dates, randomization and blinding
Acronym
IST
IRCT registration information
IRCT registration number:IRCT20211224053503N1
Registration date:2022-01-04, 1400/10/14
Registration timing:prospective
Last update:2022-06-10, 1401/03/20
Update count:2
Registration date
2022-01-04, 1400/10/14
Registrant information
Name
Jadeel Noor
Name of organization / entity
The University of Baghdad
Country
Iraq
Phone
+964 1 521 1494
Email address
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-04-01, 1401/01/12
Actual recruitment start date
2022-01-09, 1400/10/19
Actual recruitment end date
2022-04-01, 1401/01/12
Trial completion date
empty
Scientific title
Effectiveness of Incentive Spirometer on The Prevention of Postoperative Pulmonary Complications following Cardiac Surgeries
Public title
Preoperative Incentive Spirometer Breathing Exercise to Prevent Postoperative Pulmonary Complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who will agree to participate in the study based on their informed consent .
Subjects with age >50 years.
Patients who undergo open heart surgery including ( coronary and valvular) procedures
Exclusion criteria:
Patients who refuse to participate in the study.
Patients who have thoracic, abdominal, or cerebral aneurysms
recent cardiothoracic or abdominal surgery.
Age
From 50 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
128
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Parallel group trials design was used, in which subjects were randomly assigned to study group and control group.
Unit of randomization : Individual
Simple randomization technique was used for the assignment of subjects into a particular group.
flipping a coin method was chosen (heads - control, tails - intervention).
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single-blinded, since the participants are intentionally kept unaware of which of the two groups ( study and control groups) they have been assigned
Placebo
Not used
Assignment
Other
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
2021-12-08, 1400/09/17
Ethics committee reference number
2395
Health conditions studied
1
Description of health condition studied
Postoperative pulmonary complications
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The incidence of postoperative pulmonary complications
Timepoint
Subjects response to the intervention will be within one week of the first meeting to examine the effectiveness of the intervention on preventing pulmonary complications
Method of measurement
Diagnosis of pulmonary complications from patients' records, results of Peak Expiratory Flow Rate and Arterial Blood Gases
Secondary outcomes
1
Description
Peak Expiratory Flow Rate (PEFR)
Timepoint
Secondary outcome is measured before and after the application of intervention within one week
Method of measurement
Data will be obtained from patient's records
2
Description
Arterial Blood Gases
Timepoint
Secondary outcome is measured before and after the application of intervention within one week
Method of measurement
Data will be obtained from patient's records
3
Description
Hospital length of stay
Timepoint
Secondary outcome is measured after the application of intervention within one week
Method of measurement
Data will be obtained from patient's records
4
Description
Oxygen dependency
Timepoint
Secondary outcome is measured after the application of intervention during the postoperative phase
Method of measurement
Observation, medical records
5
Description
Intensive Care Unit stay
Timepoint
Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
Method of measurement
Data will be obtained from patient's records
6
Description
Prolonged ventilation
Timepoint
Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
Method of measurement
Data will be obtained from patient's records
Intervention groups
1
Description
Intervention group: The starting point of the intervention phase will start by instructing patients undergoing open heart surgeries to use Incentive Spirometer (IS) which is a mechanical device that provides patients with visual reinforcement to inhale in a deep and slow manner to enhance lungs reinflation which treat or prevent atelectasis, intervention group will use the IS hourly while awake for two days prior to surgery .The intervention group will be observed for 7 days to see the influence of the given intervention on preventing pulmonary complications.
Category
Treatment - Devices
2
Description
Control group: Control group will not use Incentive Spirometer(IS) before surgery ,instead they will receive the standard usual care provided by health care professionals. Control group will be be observed for 6 days to compare the incidence of postoperative pulmonary complications with those of the intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iraqi center for heart diseases
Full name of responsible person
Jadeel Al-Tuwaij
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
2
Recruitment center
Name of recruitment center
Ibn Al-Bitar center for cardiac surgery
Full name of responsible person
Jadeel-Altuwaij
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
3
Recruitment center
Name of recruitment center
Ibn Al-Nafees Cardiology Hospital
Full name of responsible person
Jadeel-Altuwaij
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Email
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Huda Baqer Hassan, PhD. Dean
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Grant name
Grant code / Reference number
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
College of Nursing, University of Baghdad
Full name of responsible person
Jadeel Al-Tuwaij
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Bab AL-Muadum
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Jadeel Al-Tuwaij
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Bab AL-Muadum
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Jadeel Al-Tuwaij
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Bab AL-Muadum
City
Baghdad
Province
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
jadeel.nour1202a@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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 and acknowledging his contribution.
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: jadeel.nour1202a@conursing.uobaghdad.edu.iq
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