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. 2015 Jan 9;2015(1):CD006962. doi: 10.1002/14651858.CD006962.pub2

Gilbert 1995.

Methods Prospectively randomized controlled trial (RCT)
Randomization method: no details in the text
Participants 76 consecutive, consenting adult patients with preexisting obesity or coagulopathy requiring central venous access. Obesity was defined as weight greater than 130% of ideal body weight for height and body mass index greater than 28. Coagulopathy was defined as a platelet count less than 50,000 thrombocytes/mm3 or an increase of greater than 30% above maximum laboratory control value for 1 or more of the following variables: prothrombin time; partial thromboplastin time; activated clotting time; or template bleeding time
Inclusion and exclusion criteria clearly defined in the text
Treatment and control groups adequately described at entry. A minimum of 4 admission details were described. 6 admission details was described (sex, weight, height, BMI, age, anatomical distinctiveness)
Participants awake and anaesthetized   
Operators: number: no details  
Experience: junior house staff, who were relatively inexperienced in using either technique, performed all cannulations under the direct supervision of attending faculty. They were instructed in ultrasound device use by listening to a prepared 5‐minute audiotape depicting arterial and venous signals. Years of postgraduate training and experience in control or ultrasonic techniques were similar among junior house staff for both groups of participants. The average operator was in the third postgraduate year and had greater familiarity with use of the control technique than the ultrasound technique
Interventions Technique:
LM: high/central approach, initially performing venipuncture with a 22‐gauge finder needle
vs
US: SmartNeedle
 
LM
Unclear whether direct or indirect puncture
Technique standardized: unclear
Head up (anti‐Trendelenburg); down (Trendelenburg)/flat; head rotation no details; only positioning was similar for all participants
Seldinger technique: catheter over needle, no details
Vessel and side: IJV no details
US
Direct puncture
Technique standardized: unclear
Head up (anti‐Trendelenburg); down (Trendelenburg)/flat; head rotation no details; only positioning was similar in all participants
Seldinger technique
Vessel and side: IJV no details
Outcomes Overall success rate (N, %)
Failure rate (N, %)
Number of attempts until success (N, SD)
Complication rate: total, arterial puncture, haematoma formation (N, %)
Carotid artery puncture was defined as inadvertent placement of any size needle or catheter into a neck vessel that yielded bright red or pulsatile blood
Haematoma formation was defined as the appearance of visible neck swelling at the site of cannulation (or attempted cannulation) and distortion of existing anatomical landmarks within 1 hour of study
Time to successful cannulation (seconds): Time for cannulation was recorded with a finder (control) or cannulation (ultrasound) needle, beginning with the initial skin puncture and ending with successful placement of a Seldinger wire, or until a given technique failed
Success with attempt number 1 (N, %)
Success rate after cross‐over (N, %)
Notes Cross‐over landmark‐guided puncture and ultrasound‐guided puncture
3 cannulation attempts were allowed with the initial randomized technique before cross‐over to 3 attempts with the alternative technique. The study was discontinued if more than 6 total attempts were required
LM: cross‐over after failure of the initial technique
17 LM → 12 (70.6%) success with Doppler
US: cross‐over after failure of the initial technique
5 Do → 2 (40%) successes with LM
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomization method: no details (B)
Allocation concealment (selection bias) Unclear risk Randomization method: no details (B)
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Subject blinded: Unclear__X__
Physician blinded: No__X__
Outcome assessor blinded: Unclear__X__
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes of participants who withdrew or were excluded after allocation were EITHER detailed separately OR included in an intention‐to‐treat analysis OR the text stated no withdrawals
Selective reporting (reporting bias) Low risk No
Other bias Low risk Participant selection: Yes _X_
Withdrawals: No _X_
Postrandomization exclusion: No _X_
Intention‐to‐treat analysis: Yes _X_
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Subject blinded: Unclear__X__
Physician blinded: No__X__
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Outcome assessor blinded: Unclear__X__
Treatment and control groups were adequately described at entry. Low risk Yes