Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-05 @ 8:23 AM
Study NCT ID:
NCT06538051
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': 'Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.', 'description': "The patients' respiratory rate were measured and compared separately in the supine semi-fowler's and lateral positions."}, {'measure': 'oxygen saturation', 'timeFrame': 'Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.', 'description': "The patients' oxygen saturation were measured and compared separately in the supine semi-fowler's and lateral positions."}, {'measure': 'Arterial blood pressure', 'timeFrame': 'Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.', 'description': "The patients' arterial blood pressure were measured and compared separately in the supine semi-fowler's and lateral positions."}, {'measure': 'pulse rate', 'timeFrame': 'Measurements were made 3 times a day (10th minute, 1st hour and 2nd hour) for 3 days.', 'description': "The patients' pulse rate were measured and compared separately in the supine semi-fowler's and lateral positions."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient position', 'nurse', 'Hemodynamic parameter', 'Intensive care unit'], 'conditions': ['Position Sense Disorders', 'Hemodynamic Instability']}, 'descriptionModule': {'briefSummary': 'Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.\n\nMaterial and Methods: The research was carried out semi-experimentally with a single-group posttest design, between November 2021 and May 2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. The study of the sample consisted of 60 patients in the ICU. Data were collected with the patient identification form and the hemodynamic parameters follow-up form. The patients were given different lying positions for 3 days. Hemodynamic parameters were measured and recorded at the 10th minute, 1st hour and 2nd hour after position changes. The measurement results obtained were compared with one-way ANOVA test.', 'detailedDescription': "Aim: The study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (MV) and spontaneous breathing.\n\nMaterial and Methods: The research was carried out semi-experimentally with a single-group posttest design, between the dates of 15.11.2021 and 15.05.2022 in the Internal Medicine Intensive Care (ICU) Unit a University Hospital. Since repeated measurements were planned in the study when determining the sample, A-priori power analysis was performed based on ANOVA repeated measures analysis and the effect size was calculated according to the etasquared value (Abd El-Aziz et al., 2021). Accordingly, the sample of the study was calculated as 34 patients to reach at least 80% power within a 95% confidence interval. The research was completed with a total of 60 patients who were spontaneously breathing (n=30) and mechanically ventilated (n=30). Data were collected with the patient identification form and the hemodynamic parameters follow-up form. Right lateral, semi Fowler's, left lateral and supine positions were applied to the patients every 2 hours between 9 am 5 pm for 3 days and then pulse rate, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation (SpO₂) were measured at 10th minute, 1st hour and 2nd hour. In data analysis, number, arithmetic mean, standard deviation, chi-square, independent groups t test and one-way ANOVA test were used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized in intensive care for at least 3 days\n* over 18 years of age\n* monitored\n* spontaneously breathing or connected to a mechanical ventilator,\n* conscious or unconscious,\n* receiving or not receiving oxygen support,\n* with or without a tracheostomy,\n* hemoglobin level of 8g/dl.\n\nExclusion Criteria:\n\n* Patients with movement restrictions\n* inotropic/vasopressor and sedative group medications\n* body temperature of 38˚C and above\n* patients receiving CPAP (Continuous Positive Airway Pressure) treatment'}, 'identificationModule': {'nctId': 'NCT06538051', 'briefTitle': 'The Effect of Lying Position on Hemodynamic Parameters in Patients With Mechanical Ventilated and Spontaneously Breathing.', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'The Effect of Lying Positions on Hemodynamic Parameters in Intensive Care Patients', 'orgStudyIdInfo': {'id': 'position'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'lying positions', 'interventionNames': ['Other: lying positions']}], 'interventions': [{'name': 'lying positions', 'type': 'OTHER', 'description': "All patients were placed in supine, semi-fowler's and lateral positions, respectively. The effects of positions on hemodynamic parameters were examined.", 'armGroupLabels': ['lying positions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09010', 'city': 'Aydin', 'country': 'Turkey (Türkiye)', 'facility': 'Sevil Olğun', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adnan Menderes University', 'investigatorFullName': 'Sevil Olğun', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}