LONFLIT 4 ‐ Kendall 2.
Study characteristics | ||
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. Blinding: outcome assessor not blinded. Lost to follow‐up: 0/66 (stocking) 2/68 (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: 134 No. analysed: 132 Age (years): mean 47 (stocking), 46.9 (control). Sex: 34 M, 30 F (stocking), 34 M, 32 F (control) ‐ based on number analysed. | |
Interventions | Stocking Group
Type of stocking: below‐knee Kendall travel sock with 20 to 30 mmHg of pressure at the ankle. Stockings were put on 2 to 3 hours before the flight.
No. randomised: 66
No. analysed: 66
Length of flight: 11 to 12 hours.
Type of seat: Economy, seat pitch 31 inches.
Route and time of flight: London to Phoenix.
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: 68 No. analysed: 66 Length of flight: 11 to 12 hours Type of seat: Economy, seat pitch 31 ins Route and time of flight: London to Phoenix Additional interventions: the same advice as the stocking group was given. |
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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: not mentioned. Other investigations performed: oedema test (ankle circumference, volume, swelling, discomfort). Additional complications reported: increased oedema in the control group. | |
Funding | Not reported. | |
Declarations of interest | Not reported. | |
Notes | See Feedback. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States 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 reported but not possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. Oedema scale described but variation possible, parametric and non‐parametric |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All accounted for, dropouts reported |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported |
Other bias | Low risk | No evidence of other bias |