Protocol summary
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Study aim
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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.
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Design
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Interventional, prospective, randomized
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Primary outcomes:
The incidence of postoperative pulmonary complications, which are scored by a pulmonologist who is blinded to patients’ allocation
General information
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Reason for update
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The reason for update is to edit some information regarding the sample age , inclusion criteria and recruitment dates, randomization and blinding
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Acronym
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IST
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IRCT registration information
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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
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Registration date
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2022-01-04, 1400/10/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-05, 1400/10/15
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Expected recruitment end date
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2022-04-01, 1401/01/12
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Actual recruitment start date
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2022-01-09, 1400/10/19
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Actual recruitment end date
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2022-04-01, 1401/01/12
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Trial completion date
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empty
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Scientific title
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Effectiveness of Incentive Spirometer on The Prevention of Postoperative Pulmonary Complications following Cardiac Surgeries
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Public title
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Preoperative Incentive Spirometer Breathing Exercise to Prevent Postoperative Pulmonary Complications
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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.
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Age
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From 50 years old to 79 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
128
Actual sample size reached:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-08, 1400/09/17
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Ethics committee reference number
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2395
Health conditions studied
1
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Description of health condition studied
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Postoperative pulmonary complications
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The incidence of postoperative pulmonary complications
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Timepoint
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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
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Method of measurement
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Diagnosis of pulmonary complications from patients' records, results of Peak Expiratory Flow Rate and Arterial Blood Gases
Secondary outcomes
1
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Description
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Peak Expiratory Flow Rate (PEFR)
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Timepoint
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Secondary outcome is measured before and after the application of intervention within one week
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Method of measurement
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Data will be obtained from patient's records
2
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Description
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Arterial Blood Gases
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Timepoint
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Secondary outcome is measured before and after the application of intervention within one week
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Method of measurement
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Data will be obtained from patient's records
3
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Description
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Hospital length of stay
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Timepoint
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Secondary outcome is measured after the application of intervention within one week
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Method of measurement
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Data will be obtained from patient's records
4
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Description
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Oxygen dependency
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Timepoint
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Secondary outcome is measured after the application of intervention during the postoperative phase
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Method of measurement
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Observation, medical records
5
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Description
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Intensive Care Unit stay
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Timepoint
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Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
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Method of measurement
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Data will be obtained from patient's records
6
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Description
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Prolonged ventilation
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Timepoint
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Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
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Method of measurement
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Data will be obtained from patient's records
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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The author of the trial is the funding source
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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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
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To whom data/document is available
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All the related files will be shared with any scientific interested parties.
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Under which criteria data/document could be used
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It may be used after seeking the author's permission and acknowledging his contribution.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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N/A
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Comments
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Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors