Patient-controlled Sedation in Port Implantation (PACSPI-1) (PACSPI-1)

Patient-controlled Sedation in Port Implantation (PACSPI-1)-a Feasibility Trial

The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).

Study Overview

• Status: Completed
• Conditions: Pain; Patient Satisfaction
• Intervention / Treatment: Drug: Propofol Alfentanil

Detailed Description

The main objective of this trial is to study the feasibility of (PCS) with propofol and alfentanil during SVP implantation.

Participants 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.

Each 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.

Participants are asked to fill in a written questionnaire to indicate pain score and satisfaction with the procedure when ready for discharge.

Adverse events, time consumption and operators satisfaction with implantation conditions are recorded periprocedural.

The 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Sweden
  • Jönköping, Sweden, 55185
    • Länssjukhuset Ryhov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients ≥18 years scheduled for SVP implantation at Ryhov County Hospital.

Description

Inclusion Criteria:

• Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital.

Exclusion Criteria:

• Inability to operate the PCS apparatus,
• Inability to communicate in Scandinavian languages.
• Patients who require general anaesthesia or patients eligible for local anaesthesia only (i.e. severe sleep apnea).
• Propofol or alfentanil allergy.
• Intake of food (or clear fluids) within six (or two) hours prior to the procedure.
• Failure to achieve peripheral vascular access.
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants maximal pain level	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.	10 minutes before discharge from recovery area

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time consumption	From procedure start (local anesthesia injection) until end of procedure (last suture).	after completion of procedure
Delivered doses of propofol and alfentanil	The total dose of given sedation and analgesia.	after completion of procedure
Grading of implantation conditions by the implanting physician	The port-implanting physicians assessment of implantation conditions during the procedure on a numeric rating scale (0=worst possible, 10= best possible)	after completion of procedure
Participants overall satisfaction	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	10 minutes before discharge from recovery area
Participants satisfaction with staff	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	10 minutes before discharge from recovery area
Participants maximal pain from arm where infusion is	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	10 minutes before discharge from recovery area
Participants satisfaction with pain treatment during implantation	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	10 minutes before discharge from recovery area
Participants evaluation of the importance of receiving sedatives during the procedure	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	10 minutes before discharge from recovery area
Participants evaluation of the importance of being in control of sedation administration	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	10 minutes before discharge from recovery area

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial puncture	Physicians assessment after completion of procedure.	after completion of procedure
Pneumothorax	Physicians assessment after completion of procedure.	after completion of procedure
Bradycardia	Defined as heart < 40/minutes during the procedure	after completion of procedure
Hypoxia	Defined as Oxygen saturation <90% or significant drop from baseline (>5% SaO2 drop) during the procedure	after completion of procedure
Airway intervention (Chin lift)	Defined as intervention by staff with chin lift during the procedure	after completion of procedure
Respiratory rate	Defined as respiratory rate <8/minute during the procedure	after completion of procedure
Sedation score at time points T1-T4	Depth of sedation measured by Observer Assessment of Alertness/Sedation Scale OAAS	during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal

Collaborators and Investigators

• Sponsor: Stefanie Seifert
• Investigators: Study Chair: Margaretha Stenmarker, MD, PhD, Region Jönköping County

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: propofol; local anesthesia; alfentanil; patient-controlled sedation; totally implantable venous access devices; subcutaneous implanted venous port; indwelling catheter
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Propofol; Alfentanil
• Other Study ID Numbers: EPM 2020-02642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlie results in a publication will be available for sharing on request.
• IPD Sharing Time Frame: The supporting information will be available from november 2020 until 6 months after publication

IPD Sharing Access Criteria

Requests for sharing IPD that underlie results in a publication can be made to the principal investigator.

The supporting information will be available on researchgate.net during the described time frame.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No