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. 2016 Sep 14;2016(9):CD004002. doi: 10.1002/14651858.CD004002.pub3

LONFLIT 4 ‐ Traveno 1

Methods Trial design: randomised controlled trial (parallel). Country principal investigators: Italy, UK, Australia. Where trial conducted: UK. Date of trial: May to July 2002. Multi‐centre: yes. Funder: multiple sources. Blinding: outcome assessor not blinded. Lost to follow‐up: 6/103 (stocking) 10/108 (control); dropouts due to low compliance or flight connection problems.
Participants Inclusion criteria: low‐ to medium‐risk participants. Participants were recruited through flight shops. Exclusion criteria: high‐risk participants defined as those with previous episodes of DVT, coagulation disorders, severe obesity, limited mobility due to bone or joint problems, neoplastic disease within the previous 2 years, large varicose veins or participants taller than 190 cm and heavier than 90 kg. No. randomised: 211. No. analysed: 195. Age (years): mean 44.5 (stocking), 45 (control). Sex: 53 M, 44 F (stocking), 54 M, 44 F (control) ‐ based on number analysed.
Interventions Stocking Group Type of stocking: below‐knee Traveno stocking with 12 to 18 mmHg of pressure at the ankle. Stockings were put on 2 to 3 hours before the flight. No. randomised: 103. No. analysed: 97. Length of flight: 7 to 8 hours. Type of seat: Economy, seat pitch 31 inches. Route and time of flight: London to New York. Additional interventions: suggestions were given to participants, i.e. mild exercise, walking, drinking water and avoiding salty food and excessive baggage restricting leg motion.
Control Group Type of control: no intervention No. randomised: 108 No. analysed: 98 Length of flight: 7 to 8 hours Type of seat: Economy, seat pitch 31 ins Route and time of flight: London to New York Additional interventions: the same advice as the stocking group was given.
Outcomes Outcomes assessed: incidence of DVT, SVT and oedema score. DVT diagnosed by: pre‐ and post‐flight ultrasound scanning using Sonosite scanners with a 7.5 to 13 MHz, high‐resolution probe (Sonosite, Bothell, WA, USA). This was done by compressing the major veins (femoral, popliteal and tibial). Site of DVT: none developed. Site of SVT: none developed. Other investigations performed: oedema test (ankle circumference, volume, swelling, discomfort). Additional complications reported: increased oedema in the control group.
Notes See Feedback.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated randomised but no further details
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) All outcomes High risk Not possible
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not reported, scale described but variation possible
Incomplete outcome data (attrition bias) All outcomes Low risk All participants accounted for
Selective reporting (reporting bias) Low risk All preplanned outcomes reported
Other bias Low risk No evidence of other bias