Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06297720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Oral Hydration After Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sore throat level by VAS (Visual Analogue Scale)', 'timeFrame': 'From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours', 'description': 'sore throat level by VAS (Visual Analogue Scale) measured by 0-10 point-scale'}, {'measure': 'Mouth dryness', 'timeFrame': 'From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours', 'description': 'Modified Schirmer tear strip test'}], 'secondaryOutcomes': [{'measure': 'post-operative nausea and vomiting (PONV)', 'timeFrame': 'From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours', 'description': 'PONV exist or not'}, {'measure': 'timing of post-operative nausea and vomiting (PONV)', 'timeFrame': 'From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours', 'description': 'PONV or not, if yes, record timing'}, {'measure': 'duration of post-operative nausea and vomiting (PONV)', 'timeFrame': 'From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours', 'description': 'PONV or not, if yes, record duration'}, {'measure': 'management of post-operative nausea and vomiting (PONV)', 'timeFrame': 'From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours', 'description': 'PONV or not, if yes, record management'}, {'measure': 'Heart Rate in PACU (Postanesthesia Care Unit)', 'timeFrame': 'From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours', 'description': 'Heart Rate (/min) in PACU (Postanesthesia Care Unit)'}, {'measure': 'Blood pressure in PACU (Postanesthesia Care Unit)', 'timeFrame': 'From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours', 'description': 'Blood pressure (mmHg) in PACU (Postanesthesia Care Unit)'}, {'measure': "Patient's satisfaction", 'timeFrame': 'Through study completion, before patients leaving PACU (Postanesthesia Care Unit)', 'description': "Patient's satisfaction measured by Likert scale (1-5)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early oral hydration', 'Sore throat'], 'conditions': ['Anesthesia', 'Intubation Complication']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:\n\n* the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.\n* the degree of improvement in sore throat and dry mouth after oral hydration.\n* the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.\n* the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.\n* patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia.\n\nParticipants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room.', 'detailedDescription': "Anesthesiologists assess the removal of the endotracheal tube post-surgery and the patient is then transferred to the recovery room for rest. The principal investigator will evaluate the consciousness status and risk of nausea and vomiting to confirm eligibility for the trial. Subsequently, the following grouping will be conducted:\n\n1. Experimental group\n\n * First, moisten the patient's throat with a cotton swab dipped in water. If no nausea or vomiting occurs after five minutes, proceed to the next stage.\n * Provide an ice cube for the patient to hold in their mouth. If no nausea or vomiting occurs after ten minutes, proceed to the next stage.\n * Offer 10-20ml water for the patient to drink under medical supervision. If no nausea or vomiting occurs and the patient requests more water, administer 10-20ml of water every ten minutes, assessing for any adverse effects each time. The total water intake should not exceed 500ml.\n2. Comparison group - standard care without any intervention\n\nEvaluate the level of throat pain using VAS (Visual Analogue Scale) score, the incidence, timing, frequency of post-operative nausea and vomiting, the level of mouth dryness, the satisfaction of patients in recovery room, and the vital signs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 18 to 70.\n* Anesthesia physical status classification III or below\n* Body Mass Index 30 or below\n* Elective video-assisted thoracoscopic surgery\n\nExclusion Criteria:\n\n* Pre-operative throat pain\n* Impaired mental status\n* Tendency to choke (inc. dysphagia, stroke hx.)\n* Nil Per Os (NPO) less than 8 hours\n* Pregnancy\n* Nausea and vomiting in Operating room or Post-anesthesia care unit'}, 'identificationModule': {'nctId': 'NCT06297720', 'briefTitle': 'Early Oral Hydration After Thoracoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Safety and Feasibility of Early Oral Hydration After Video-assisted Thoracoscopic Surgery: A Prospective, Randomized, and Controlled Study', 'orgStudyIdInfo': {'id': '2401110013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral hydration', 'description': 'wet swab-ice cube-small amount of water', 'interventionNames': ['Behavioral: Oral hydration']}, {'type': 'NO_INTERVENTION', 'label': 'No hydration', 'description': 'According to routine care, no oral fluid supplementation is provided.'}], 'interventions': [{'name': 'Oral hydration', 'type': 'BEHAVIORAL', 'description': "* Researchers moisten the patient's throat with a wet cotton swab. If no nausea or vomiting occurs after five minutes, proceed to the next stage.\n* Provide an ice cube of potable water for the patient to hold in their mouth. If no nausea or vomiting occurs after ten minutes, proceed to the next stage.\n* Offer 10-20ml of potable water for the patient to drink under medical supervision. If no nausea or vomiting occurs and the patient requests more water, administer 10-20ml every ten minutes, assessing for any adverse effects each time. The total water intake should not exceed 500ml.", 'armGroupLabels': ['Oral hydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33380', 'city': 'Taoyuan District', 'country': 'Taiwan', 'contacts': [{'name': 'JUN-YU CHEN', 'role': 'CONTACT'}], 'facility': 'ChangGung MH', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Ting Ting Wang, Master', 'role': 'CONTACT', 'email': 'ttwang94anes@gmail.com', 'phone': '+886978316935'}], 'overallOfficials': [{'name': 'JUN-YU CHEN', 'role': 'STUDY_CHAIR', 'affiliation': '+886937020809'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}