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چکیده پروتکل
II. To determine the effect of using incentive spirometer on the prevention of postoperative pulmonary complications among cardiac surgical patients.
II. To investigate the effect of using incentive spirometer on study group according to the incidence of postoperative pulmonary complications, oxygenation status, length of hospitalization and the need for mechanical ventilation.
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 socio-demographic and clinical factors associated with increased risk for the development of postoperative pulmonary complications following cardiac surgeries.
II. ToI.To determine the effect preoperative use of using incentive spirometeran Incentive Spirometer has on the prevention ofpreventing postoperative pulmonary complications among cardiac surgical patients. II. To investigate the effect of using incentive spirometer on study group according to the incidence of postoperative pulmonary complications, oxygenation status, length of hospitalization and the need for mechanical ventilation. III. ToIII.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 >18 years.
Patients who undergo cardiac surgery under general anesthesia.
Patients who are obese ,smokers and have underlying respiratory disease
Exclusion criteria:
Patients who refuse to participate in the study.
Patients who have undergone tracheostomy.
Patients in which incentive spirometer is contraindicated
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. Subjects with age >1850 years. Patients who undergo cardiacopen heart surgery under general anesthesia. Patients who are obese ,smokersincluding ( coronary and have underlying respiratory diseasevalvular) procedures Exclusion criteria: Patients who refuse to participate in the study. Patients who have undergone tracheostomy.thoracic, abdominal, or cerebral aneurysms Patients in which incentive spirometer is contraindicatedRecent cardiothoracic or abdominal surgery.
Intervention group will be instructed to use Incentive Spirometer hourly while awake for two days prior to surgery. The intervention group will be observed for 6 days to see the influence of using incentive spirometer on preventing postoperative pulmonary complications.
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.
InterventionPatients allocated to the intervention group will be instructedwere trained to use Incentive Spirometerthe 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 for two days prior to surgery. The intervention group will be observed for 6 days to seeuntil the influenceday of using incentive spirometer on preventing postoperative pulmonary complicationsthe surgical operation.
The incidence of postoperative pulmonary complications
Primary outcomes:
The incidence of postoperative pulmonary complications, which are scored by a pulmonologist who is blinded to patients’ allocation
Primary outcomes: The incidence of postoperative pulmonary complications, which are scored by a pulmonologist who is blinded to patients’ allocation
اطلاعات عمومی
18
50
1850
خالی
79
79
خالی
سال
year
بلی
خیر
1
اختصاص غیر تصادفی به گروههای مداخله و کنترل
اختصاص تصادفی به گروههای مداخله و کنترل
nrandrand
کور نشده است
یک سویه کور
notblsingl
1
1
1
1
موازی
موارد دیگر
paralother
750
128
750128
خالی
64
64
2022-04-30, ۱۴۰۱/۰۲/۱۰
2022-04-01, ۱۴۰۱/۰۱/۱۲
2022-04-3001 00:00:00
خالی
2022-01-09, ۱۴۰۰/۱۰/۱۹
2022-01-09 00:00:00
خالی
2022-04-01, ۱۴۰۱/۰۱/۱۲
2022-04-01 00:00:00
خالی
The reason for update is to edit some information regarding the sample age , inclusion criteria and recruitment dates, randomization and blinding
The reason for update is to edit some information regarding the sample age , inclusion criteria and recruitment dates, randomization and blinding
Effectiveness of Incentive Spirometer on The Prevention of Post-Operative Pulmonary Complications following Cardiac Surgeries
Preoperative Incentive Spirometer Breathing Exercise to Prevent Postoperative Pulmonary Complications
Effectiveness ofPreoperative Incentive Spirometer on The Prevention of Post-OperativeBreathing Exercise to Prevent Postoperative Pulmonary Complications following Cardiac Surgeries
Patients who will agree to participate in the study based on their informed consent .
Subjects with age >18 years.
Patients who undergo cardiac surgery under general anesthesia.
Patients who are smokers, obese, with underlying respiratory disease.
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
Patients who will agree to participate in the study based on their informed consent . Subjects with age >1850 years. Patients who undergo cardiacopen heart surgery under general anesthesia. Patients who are smokers, obese, with underlying respiratory disease.including ( coronary and valvular) procedures
Patients who refuse to participate in the study.
Patients who have undergone tracheostomy.
Patients in which incentive spirometer is contraindicated.
Patients who refuse to participate in the study.
Patients who have thoracic, abdominal, or cerebral aneurysms
recent cardiothoracic or abdominal surgery.
Patients who refuse to participate in the study. Patients who have undergone tracheostomythoracic, abdominal, or cerebral aneurysms recent cardiothoracic or abdominal surgery. Patients in which incentive spirometer is contraindicated.
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).
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).
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
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
متغیر پیامد ثانویه
#1
Length of hospital stay
Hospital length of stay
LengthHospital length of hospital stay
#2
خالی
Oxygen dependency
Oxygen dependency
خالی
Secondary outcome is measured after the application of intervention during the postoperative phase
Secondary outcome is measured after the application of intervention during the postoperative phase
خالی
Observation, medical records
Observation, medical records
#3
خالی
Intensive Care Unit stay
Intensive Care Unit stay
خالی
Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
خالی
Data will be obtained from patient's records
Data will be obtained from patient's records
#4
خالی
Prolonged ventilation
Prolonged ventilation
خالی
Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
Secondary outcome is measured after the application of intervention during the postoperative phase in the intensive care unit
خالی
Data will be obtained from patient's records
Data will be obtained from patient's records
گروههای مداخله
#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 6 days to see the influence of the given intervention on preventing pulmonary complications.
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 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 67 days to see the influence of the given intervention on preventing pulmonary complications.
برنامه انتشار
yes
undecided
yesundecided
yes
no
yesno
چکیده پروتکل
هدف ازمطالعه
طراحی
نحوه و محل انجام مطالعه
شرکت کنندگان/شرایط ورود و عدم ورود
گروههای مداخله
متغیرهای پیامد اصلی
اطلاعات عمومی
علت بروز رسانی
نام اختصاری
IST
اطلاعات ثبت در مرکز
شماره ثبت کارآزمایی در مرکز:IRCT20211224053503N1
تاریخ تایید ثبت در مرکز:2022-01-04, ۱۴۰۰/۱۰/۱۴
زمانبندی ثبت:prospective
آخرین بروز رسانی:2022-04-16, ۱۴۰۱/۰۱/۲۷
تعداد بروز رسانیها:2
تاریخ تایید ثبت در مرکز
2022-01-04, ۱۴۰۰/۱۰/۱۴
اطلاعات تماس ثبت کننده
نام
نام سازمان / نهاد
کشور
عراق
تلفن
+964 1 521 1494
آدرس ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
وضعیت بیمار گیری
بیمار گیری تمام شده
منبع مالی
تاریخ شروع بیمار گیری مورد انتظار
2022-01-05, ۱۴۰۰/۱۰/۱۵
تاریخ پایان بیمار گیری مورد انتظار
2022-04-01, ۱۴۰۱/۰۱/۱۲
تاریخ شروع بیمارگیری تحقق یافته
2022-01-09, ۱۴۰۰/۱۰/۱۹
تاریخ پایان بیمارگیری تحقق یافته
2022-04-01, ۱۴۰۱/۰۱/۱۲
تاریخ خاتمه کارآزمایی
خالی
عنوان علمی کارآزمایی
عنوان عمومی کارآزمایی
هدف اصلی مطالعه
پیشگیری
شرایط عمده ورود و عدم ورود به مطالعه
سن
از سن 50 ساله تا سن 79 ساله
جنسیت
هر دو
فاز مطالعه
مصداق ندارد
گروههای کور شده در مطالعه
شرکت کننده
مراقب بالینی
حجم نمونه کل
حجم نمونه پیشبینی شده:
128
حجم نمونه تحقق یافته:
64
تصادفی سازی (نظر محقق)
اختصاص تصادفی به گروههای مداخله و کنترل
توصیف نحوه تصادفی سازی
کور سازی (به نظر محقق)
یک سویه کور
توصیف نحوه کور سازی
دارو نما
ندارد
اختصاص به گروههای مطالعه
موارد دیگر
سایر مشخصات طراحی مطالعه
کد ثبت در سایر مراکز ثبت بینالمللی
خالی
تاییدیه کمیتههای اخلاق
1
کمیته اخلاق
نام کمیته اخلاق
آدرس خیابان
شهر
کد پستی
10001
تاریخ تایید
2021-12-08, ۱۴۰۰/۰۹/۱۷
کد کمیته اخلاق
2395
بیماریهای (موضوعات) مورد مطالعه
1
شرح
کد ICD-10
توصیف کد ICD-10
متغیر پیامد اولیه
1
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
متغیر پیامد ثانویه
1
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
2
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
3
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
4
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
5
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
6
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
گروههای مداخله
1
شرح مداخله
گروه مداخله:
طبقه بندی
درمانی - وسایل
2
شرح مداخله
گروه کنترل:
طبقه بندی
مصداق ندارد
مراکز بیمار گیری
1
مرکز بیمار گیری
نام مرکز بیمار گیری
نام کامل فرد مسوول
آدرس خیابان
شهر
کد پستی
10001
تلفن
+964 1 415 0076
ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
آدرس صفحه وب
https://www.medicalcity.gov.iq/ar/contact-us
2
مرکز بیمار گیری
نام مرکز بیمار گیری
نام کامل فرد مسوول
آدرس خیابان
شهر
کد پستی
10001
تلفن
+964 1 415 0076
ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
آدرس صفحه وب
https://www.medicalcity.gov.iq/ar/contact-us
3
مرکز بیمار گیری
نام مرکز بیمار گیری
نام کامل فرد مسوول
آدرس خیابان
شهر
کد پستی
10001
تلفن
+964 1 415 0076
ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
آدرس صفحه وب
https://www.medicalcity.gov.iq/ar/contact-us
حمایت کنندگان / منابع مالی
1
حمایت کننده مالی
نام سازمان / نهاد
نام کامل فرد مسوول
آدرس خیابان
شهر
کد پستی
10001
تلفن
+964 1 521 1494
ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
آدرس صفحه وب
https://www.medicalcity.gov.iq/ar/contact-us
ردیف بودجه
کد بودجه
آیا منبع مالی همان سازمان یا نهاد حمایت کننده مالی است؟
خیر
عنوان منبع مالی
درصد تامین مالی مطالعه توسط این منبع
100
بخش عمومی یا خصوصی
عمومی
مبدا اعتبار از داخل یا خارج کشور
داخلی
طبقه بندی منابع اعتبار خارحی
خالی
کشور مبدا
طبقه بندی موسسه تامین کننده اعتبار
موارد دیگر
فرد مسوول پاسخگویی عمومی کارآزمایی
اطلاعات تماس
نام سازمان / نهاد
نام کامل فرد مسوول
موقعیت شغلی
آخرین مدرک تحصیلی
لیسانس
سایر حوزههای کاری/تخصصها
آدرس خیابان
شهر
استان
کد پستی
10001
تلفن
+964 1 521 1494
ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
آدرس صفحه وب
https://www.medicalcity.gov.iq/ar/contact-us
فرد مسوول پاسخگویی علمی مطالعه
اطلاعات تماس
نام سازمان / نهاد
نام کامل فرد مسوول
موقعیت شغلی
آخرین مدرک تحصیلی
لیسانس
سایر حوزههای کاری/تخصصها
آدرس خیابان
شهر
استان
کد پستی
10001
تلفن
+964 1 521 1494
ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
آدرس صفحه وب
https://www.medicalcity.gov.iq/ar/contact-us
فرد مسوول بهروز رسانی اطلاعات
اطلاعات تماس
نام سازمان / نهاد
نام کامل فرد مسوول
موقعیت شغلی
آخرین مدرک تحصیلی
لیسانس
سایر حوزههای کاری/تخصصها
آدرس خیابان
شهر
استان
کد پستی
10001
تلفن
+964 1 521 1494
ایمیل
jadeel.nour1202a@conursing.uobaghdad.edu.iq
آدرس صفحه وب
https://www.medicalcity.gov.iq/ar/contact-us
برنامه انتشار
فایل داده شرکت کنندگان (IPD)
بله - برنامهای برای انتشار آن وجود دارد
پروتکل مطالعه
بله - برنامهای برای انتشار آن وجود دارد
نقشه آنالیز آماری
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
فرم رضایتنامه آگاهانه
خیر - برنامهای برای انتشار آن وجود ندارد
گزارش مطالعه بالینی
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
کدهای استفاده شده در آنالیز
مصداق ندارد
نظام دستهبندی داده (دیکشنری داده)
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
عنوان و جزییات بیشتر در مورد داده/مستند
بازه زمانی امکان دسترسی به داده/مستند
کسانی که اجازه دارند به داده/مستند دسترسی پیدا کنند
به چه منظور و تحت چه شرایطی داده/مستند قابل استفاده است
برای دریافت داده/مستند به چه کسی یا کجا مراجعه شود
یک درخواست برای داده/مستند چه فرایندی را طی میکند