A pilot study assessing the effectiveness and safety of patient-controlled sedation during the insertion of a central venous line.

Not Applicable

• Conditions: Radiologically-guided insertion of a central venous line for patients undergoing chemotherapy, dialysis, or other conditions requiring high flow long term central line access (eg treatment of cystic fibrosis or other chronic disease); Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12614001280695
• Lead Sponsor: Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients referred to the Radiology Department for elective central venous line insertion (for example, but not limited to: Hickman line for chemotherapy or antibiotics, Portacath for commencement urgent dailysis)
Males and females aged 18 to 75
No allergy to fentanyl and/or midazolam
ASA score 1 to 3
Signed study participant information and Consent form.

Exclusion Criteria

Pregnancy
Coagulopathy (INR > 2, platelets < 50)
Abnormal renal function with a calculated e-GFR <40;
Allergy to contrast;
ASA score 4 to 6
Therapeutic heparinisation or current thrombolysis
Sepsis
Cellulitis or dermatitis at planned insertion site
On protease inhibitor antiretroviral drugs
Altered conscious state
Head injury
Significant hepatic dysfunction
Head or neck tumours
Not fasted for at least 4 hours
Contraindication to administration of inspired oxygen
Unable to sign participant information and Consent form
Lacks capacity to provide study consent for self

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with procedure and quality of recovery measured with the postoperative Alfred Quality of Recovery Tool and the 10 point VAS Patient Satisfaction Survey [Measured at 2 hours post the procedure];Patient duration of amnesia for specified stimuli during the procedure, measured by questioning patients about the stimuli 1 hour after the procedure[1 hour after the procedure];Success of sedation and analgesia measured by the Victorian Standard Sedation Score and Ramsay Sedation Score[Measured at selected time points during the procedure and immediately after the procedure:<br>Time 1 - Pre-procedure<br>Time 2 - After time out the procedure begins and the PCA is active<br>Time 3 - Prep and drape<br>Time 4 - Local anaesthetic<br>Time 5 - During the 'tunneling' process of the ventral line procedure<br>Time 6 - End of procedure - drapes removed, PCA removed]