Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 5:46 AM
Study NCT ID:
NCT04631393
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2020-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-controlled Sedation in Port Implantation (PACSPI-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-10', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Arterial puncture', 'timeFrame': 'after completion of procedure', 'description': 'Physicians assessment after completion of procedure.'}, {'measure': 'Pneumothorax', 'timeFrame': 'after completion of procedure', 'description': 'Physicians assessment after completion of procedure.'}, {'measure': 'Bradycardia', 'timeFrame': 'after completion of procedure', 'description': 'Defined as heart \\< 40/minutes during the procedure'}, {'measure': 'Hypoxia', 'timeFrame': 'after completion of procedure', 'description': 'Defined as Oxygen saturation \\<90% or significant drop from baseline (\\>5% SaO2 drop) during the procedure'}, {'measure': 'Airway intervention (Chin lift)', 'timeFrame': 'after completion of procedure', 'description': 'Defined as intervention by staff with chin lift during the procedure'}, {'measure': 'Respiratory rate', 'timeFrame': 'after completion of procedure', 'description': 'Defined as respiratory rate \\<8/minute during the procedure'}, {'measure': 'Sedation score at time points T1-T4', 'timeFrame': 'during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal', 'description': 'Depth of sedation measured by Observer Assessment of Alertness/Sedation Scale OAAS'}], 'primaryOutcomes': [{'measure': 'Participants maximal pain level', 'timeFrame': '10 minutes before discharge from recovery area', 'description': 'Participants assessment of maximal pain level experienced during the procedure using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Procedural time consumption', 'timeFrame': 'after completion of procedure', 'description': 'From procedure start (local anesthesia injection) until end of procedure (last suture).'}, {'measure': 'Delivered doses of propofol and alfentanil', 'timeFrame': 'after completion of procedure', 'description': 'The total dose of given sedation and analgesia.'}, {'measure': 'Grading of implantation conditions by the implanting physician', 'timeFrame': 'after completion of procedure', 'description': 'The port-implanting physicians assessment of implantation conditions during the procedure on a numeric rating scale (0=worst possible, 10= best possible)'}, {'measure': 'Participants overall satisfaction', 'timeFrame': '10 minutes before discharge from recovery area', 'description': 'Participants assessment of overall satisfaction experienced during the procedure using a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire'}, {'measure': 'Participants satisfaction with staff', 'timeFrame': '10 minutes before discharge from recovery area', 'description': 'Participants assessment of satisfaction with the staff using a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire'}, {'measure': 'Participants maximal pain from arm where infusion is', 'timeFrame': '10 minutes before discharge from recovery area', 'description': 'Participants assessment of pain from arm with the infusion using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire'}, {'measure': 'Participants satisfaction with pain treatment during implantation', 'timeFrame': '10 minutes before discharge from recovery area', 'description': 'Participants assessment of satisfaction with pain treatment on a numeric rating scale from 0-10 (0=not satisfied at all, 10=very satisfied) on patient questionnaire'}, {'measure': 'Participants evaluation of the importance of receiving sedatives during the procedure', 'timeFrame': '10 minutes before discharge from recovery area', 'description': 'Participants assessment of the importance of receiving sedatives on a numeric rating scale from 0-10 (0=not important, 10=very important) on patient questionnaire'}, {'measure': 'Participants evaluation of the importance of being in control of sedation administration', 'timeFrame': '10 minutes before discharge from recovery area', 'description': 'Participants assessment of the importance of being in control of sedation administration on a numeric rating scale from 0-10 (0=not important, 10=very important) on patient questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient-controlled sedation', 'totally implantable venous access devices', 'subcutaneous implanted venous port', 'local anesthesia', 'propofol', 'alfentanil', 'indwelling catheter'], 'conditions': ['Pain', 'Patient Satisfaction']}, 'referencesModule': {'references': [{'pmid': '31005243', 'type': 'BACKGROUND', 'citation': 'Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.'}, {'pmid': '30295410', 'type': 'BACKGROUND', 'citation': 'Clements W, Sneddon D, Kavnoudias H, Joseph T, Goh GS, Koukounaras J, Snow T. Randomized and controlled study comparing patient controlled and radiologist controlled intra-procedural conscious sedation, using midazolam and fentanyl, for patients undergoing insertion of a central venous line. J Med Imaging Radiat Oncol. 2018 Dec;62(6):781-788. doi: 10.1111/1754-9485.12817. Epub 2018 Oct 8.'}, {'pmid': '29750696', 'type': 'BACKGROUND', 'citation': 'Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361.'}, {'pmid': '31478938', 'type': 'BACKGROUND', 'citation': 'Grossmann B, Nilsson A, Sjoberg F, Nilsson L. Patient-controlled Sedation During Flexible Bronchoscopy: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2020 Apr;27(2):77-85. doi: 10.1097/LBR.0000000000000610.'}, {'pmid': '23432403', 'type': 'RESULT', 'citation': 'Taxbro K, Berg S, Hammarskjold F, Hanberger H, Malmvall BE. A prospective observational study on 249 subcutaneous central vein access ports in a Swedish county hospital. Acta Oncol. 2013 Jun;52(5):893-901. doi: 10.3109/0284186X.2013.770601. Epub 2013 Feb 22.'}, {'pmid': '37588584', 'type': 'DERIVED', 'citation': 'Seifert S, Taxbro K, Hammarskjold F. Patient-Controlled Sedation in Port Implantation (PACSPI 1) - A feasibility trial. BJA Open. 2022 Jul 31;3:100026. doi: 10.1016/j.bjao.2022.100026. eCollection 2022 Sep.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).', 'detailedDescription': 'The main objective of this trial is to study the feasibility of (PCS) with propofol and alfentanil during SVP implantation.\n\nParticipants included in the study are able to administer a combination of propofol and alfentanil using a patient-controlled sedation pump. This allows the patient to self-control their sedation/analgesia during SVP implantation. The pump enables the patient via a hand-held button to trigger the release of a single bolus. A bolus of 0.5ml programmed into the pump contains a combination of 4.5mg propofol and 25µg alfentanil and is administered under a 7 second period resulting in a maximal amount of 8 bolus doses per minute.\n\nEach SVP implantation procedure is separated into four time points at which sedation scores are recorded. Patients are monitored by anaesthesia staff and SVP implantation is performed by an anaesthesiologist according to hospital protocol.\n\nParticipants are asked to fill in a written questionnaire to indicate pain score and satisfaction with the procedure when ready for discharge.\n\nAdverse events, time consumption and operators satisfaction with implantation conditions are recorded periprocedural.\n\nThe result of this trial will provide guidance for a larger randomized trial (PACSPI-2) comparing several clinically relevant aspects of the use of PCS and local anesthesia (LA) versus LA alone during SVP implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital.\n\nExclusion Criteria:\n\n* Inability to operate the PCS apparatus,\n* Inability to communicate in Scandinavian languages.\n* Patients who require general anaesthesia or patients eligible for local anaesthesia only (i.e. severe sleep apnea).\n* Propofol or alfentanil allergy.\n* Intake of food (or clear fluids) within six (or two) hours prior to the procedure.\n* Failure to achieve peripheral vascular access.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04631393', 'acronym': 'PACSPI-1', 'briefTitle': 'Patient-controlled Sedation in Port Implantation (PACSPI-1)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Jönköping County'}, 'officialTitle': 'Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial', 'orgStudyIdInfo': {'id': 'EPM 2020-02642'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Propofol Alfentanil', 'type': 'DRUG', 'otherNames': ['Propofol/Alfentanil self-administration'], 'description': 'Propofol and Alfentanil are self-administered by the participant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55185', 'city': 'Jönköping', 'country': 'Sweden', 'facility': 'Länssjukhuset Ryhov', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}], 'overallOfficials': [{'name': 'Margaretha Stenmarker, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Region Jönköping County'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The supporting information will be available from november 2020 until 6 months after publication', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication will be available for sharing on request.', 'accessCriteria': 'Requests for sharing IPD that underlie results in a publication can be made to the principal investigator.\n\nThe supporting information will be available on researchgate.net during the described time frame.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefanie Seifert', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stefanie Seifert', 'investigatorAffiliation': 'Region Jönköping County'}}}}