Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-31 @ 2:10 AM
Study NCT ID:
NCT06039995
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2023-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-15'}], 'estimatedResultsFirstSubmitDate': '2025-12-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-09-10', 'studyFirstSubmitQcDate': '2023-09-10', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Ventilator-Associated Pneumonia (VAP)', 'timeFrame': 'The time frame for assessing the incidence of VAP in this study spans the entire three-month duration of the research conducted at Services Hospital, Lahore.', 'description': 'This outcome measures the occurrence of Ventilator-Associated Pneumonia (VAP) among patients who are on mechanical ventilation in the intensive care unit (ICU). It serves as a critical indicator of the effectiveness of the intervention, which includes adjuvant oral care, in reducing the risk of VAP.'}], 'secondaryOutcomes': [{'measure': 'Duration of ICU Stay', 'timeFrame': 'These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.', 'description': 'The duration of ICU stay will be recorded for each patient. This data will help evaluate whether the intervention affects the length of ICU stay and potentially reduces healthcare resource utilization'}, {'measure': 'Mortality Rates', 'timeFrame': 'These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.', 'description': 'Mortality rates in both the control and intervention groups will be compared to assess if the adjuvant oral care intervention has an impact on patient survival during their ICU stay.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia, Ventilator-Associated']}, 'descriptionModule': {'briefSummary': 'A Randomized Controlled Trial (RCT) at Services Hospital, Lahore, aims to reduce Ventilator-Associated Pneumonia (VAP) incidence and mortality rates while shortening ICU stays in mechanically ventilated patients by adding adjuvant oral care to traditional practices.\n\nStudy Objectives:\n\nFocus: ICU patients on mechanical ventilation. Question: Does adjuvant oral care reduce VAP rates and ICU stays?\n\nMethodology:\n\nSample: Minimum 100 eligible subjects via convenient sampling. Randomization: Computer software for unbiased group allocation. Interventions: Intervention group gets Chlorhexidine mouthwash, toothbrushing, and oral gel; control group gets 0.2% Chlorhexidine mouthwash.\n\nMeasures: Evaluate VAP using Modified Clinical Pulmonary Infection Score (MCPIS) and compare demographic data.\n\nStatistical Analysis: SPSS v22 to analyze data.\n\nExpected Impact:\n\nPotential to reduce VAP and improve ICU patient outcomes. Cost-effective treatment with adjuvant oral care. Shorter ICU stays, relieving VAP burden. Enhanced patient care, reduced mortality, and resource strain. Aligns with reducing VAP incidence and improving ICU patient care.', 'detailedDescription': 'The study in question is a Randomized Controlled Trial (RCT) conducted at Services Hospital, Lahore, over a three-month duration. It aims to assess the effects of including adjuvant oral care as part of traditional oral care in reducing the incidence and mortality rates of Ventilator-Associated Pneumonia (VAP) while also shortening the length of ICU stays among patients on mechanical ventilation. This research holds the potential to bring significant improvements to patient care and reduce the burden of VAP in critical care settings.\n\nStudy Objectives:\n\nPopulation Focus: The study focuses on patients admitted to the intensive care unit (ICU) who are receiving mechanical ventilation.\n\nResearch Question: The central question this study seeks to answer is: Does the inclusion of adjuvant oral care alongside traditional oral care reduce the incidence and mortality rates of VAP and shorten the length of ICU stay among patients on mechanical ventilation?\n\nMethodology:\n\nSample Selection: The study aims to include a minimum of 100 subjects who meet the inclusion criteria. These subjects will be selected through convenient sampling.\n\nRandomization: To ensure unbiased allocation, subjects will be randomly assigned to either the control group or the intervention group using computer software.\n\nInterventions: The intervention group will receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. In contrast, the control group will receive traditional oral care involving the use of 0.2% Chlorhexidine mouthwash only.\n\nOutcome Measures: The study will evaluate the incidence of VAP by employing the Modified Clinical Pulmonary Infection Score (MCPIS). Additionally, demographic characteristics such as age, gender, smoking history, duration of ICU stay, and mortality rates will be compared between the two groups.\n\nStatistical Analysis: Data analysis will be conducted using SPSS version 22, employing appropriate statistical methods and tests to draw meaningful conclusions.\n\nExpected Impact:\n\nThe findings of this study hold significant potential to reduce VAP rates and improve patient outcomes in ICU settings. The incorporation of toothbrushing and moisturizing gel alongside Chlorhexidine mouthwash may enhance the cost-effectiveness of treatment and benefit healthcare professionals. This approach could potentially lead to shorter ICU stays, ultimately reducing the burden of VAP in critical care settings.\n\nFurthermore, the implementation of comprehensive oral care practices beyond traditional methods has the potential to improve patient care, decrease mortality rates, and alleviate the strain on healthcare resources by potentially reducing the duration of ICU stays. In sum, this research contributes to the broader goal of reducing the incidence of VAP and enhancing overall patient care in intensive care units.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients on intensive mechanical ventilation aged 18-65 years of either sex with oral ETT in situ.\n* MCPIS score between 0 to 5 on first day of admission at ICU\n\nExclusion Criteria:\n\n* More than 48 hours of mechanical ventilation before ICU admission.\n* Previous history of respiratory illness.\n* Immunocompromised.\n* Ongoing sepsis.\n* Pregnancy.\n* Presence of dentures.'}, 'identificationModule': {'nctId': 'NCT06039995', 'briefTitle': 'The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia.', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'VAP RCT 23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(Adjuvant Oral Care) Intervention Group', 'description': "This group represents the intervention arm of the study. Patients in this arm receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This group is the focus of the study's investigation to determine the effectiveness of adjuvant oral care in reducing the incidence of Ventilator-Associated Pneumonia (VAP) and improving patient outcomes.", 'interventionNames': ['Procedure: Comprehensive Oral Care', 'Device: Mechanical Tooth Brushing using 0.2% Chlorhexidine', 'Device: Moisturizing Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Traditional Oral Care) Control Group', 'description': 'This group represents the control arm of the study. Patients in this arm receive traditional oral care, which involves the use of 0.2% Chlorhexidine mouthwash only.', 'interventionNames': ['Procedure: Traditional Oral Care', 'Device: Oral care using Cotton swab dipped in 0.2% Chlorhexidine']}], 'interventions': [{'name': 'Comprehensive Oral Care', 'type': 'PROCEDURE', 'otherNames': ['Adjuvant oral care as a component of traditional oral care'], 'description': 'The intervention mentioned in this study involves a combination of oral care strategies for patients in the intervention group. These strategies include:\n\nChlorhexidine Mouthwash: Patients in the intervention group will receive Chlorhexidine mouthwash. Chlorhexidine is known for its effectiveness in maintaining oral hygiene.\n\nToothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene.\n\nMoisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues.\n\nThese interventions aim to enhance oral care beyond traditional methods, potentially reducing the risk of Ventilator-Associated Pneumonia (VAP) and improving overall patient outcomes in the intensive care unit (ICU).', 'armGroupLabels': ['(Adjuvant Oral Care) Intervention Group']}, {'name': 'Traditional Oral Care', 'type': 'PROCEDURE', 'description': 'In the control arm, patients receive the intervention known as "Traditional Oral Care." This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene.', 'armGroupLabels': ['(Traditional Oral Care) Control Group']}, {'name': 'Mechanical Tooth Brushing using 0.2% Chlorhexidine', 'type': 'DEVICE', 'description': 'Toothbrushing: In addition to Chlorhexidine mouthwash, patients in the intervention group will undergo toothbrushing. This involves cleaning the teeth and surrounding oral tissues to ensure thorough oral hygiene.', 'armGroupLabels': ['(Adjuvant Oral Care) Intervention Group']}, {'name': 'Moisturizing Gel', 'type': 'DEVICE', 'otherNames': ['Veramin'], 'description': 'Moisturizing Gel Application: The intervention group will also receive the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This helps in maintaining the moisture content of the oral tissues.', 'armGroupLabels': ['(Adjuvant Oral Care) Intervention Group']}, {'name': 'Oral care using Cotton swab dipped in 0.2% Chlorhexidine', 'type': 'DEVICE', 'description': 'This involves the use cotton swab dipped in 0.2% Chlorhexidine mouthwash for oral hygiene', 'armGroupLabels': ['(Traditional Oral Care) Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'NOT_YET_RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Akash Samuel, MS Nursing', 'role': 'CONTACT'}], 'facility': 'University of Health Sciences', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Lahore', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Recruiment Focal Person', 'role': 'CONTACT', 'email': 'alotaibiwaad02@gmail.com', 'phone': '+923326269439'}], 'facility': 'Services Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Akash Samuel, MS Nursing', 'role': 'CONTACT', 'email': 'akashsamuel20@gmail.com', 'phone': '03421532346'}], 'overallOfficials': [{'name': 'Akash Samuel, MS Nursing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Health Sciences Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Akash Samuel', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}