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IRCT20211224053503N1 IRCT 2022-01-04 College of Nursing, University of Baghdad Preoperative Incentive Spirometer Breathing Exercise to Prevent Postoperative Pulmonary Complications IST Effectiveness of Incentive Spirometer on The Prevention of Postoperative Pulmonary Complications following Cardiac Surgeries 2022-01-05 anticipated 128 Complete https://irct.ir/trial/60920 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, 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 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. N/A Postoperative pulmonary complications. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 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: All the related files will be shared with any scientific interested parties. Conditions: It may be used after seeking the author's permission and acknowledging his contribution. Where to obtain: 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 How to obtain: N/A Comments: Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors
public Jadeel Al-Tuwaij
Bab AL-Muadum
Baghdad Iraq 10001 +964 1 521 1494 jadeel.nour1202a@conursing.uobaghdad.edu.iq College of Nursing, University of Baghdad scientific Jadeel Al-Tuwaij
Bab AL-Muadum
Baghdad Iraq 10001 +964 1 521 1494 jadeel.nour1202a@conursing.uobaghdad.edu.iq College of Nursing, University of Baghdad Iraq Iraq Iraq 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 50 years 79 years Both Patients who refuse to participate in the study. Patients who have thoracic, abdominal, or cerebral aneurysms recent cardiothoracic or abdominal surgery. Treatment - Devices N/A 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. 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. 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. 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. 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. 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. Oxygen dependency. Timepoint: Secondary outcome is measured after the application of intervention during the postoperative phase. Method of measurement: Observation, medical records. 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. 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. The author of the trial is the funding source Approved 2021-12-08 Research Ethical Approval Committee, at the College of Nursing Bab AL-Muadum Baghdad Baghdad Iraq