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Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial.

ABSTRACT: Colonoscopes are designed with balance between flexibility, required to negotiate angulations, and stiffness, required to counteract the propensity for looping in unfixed sections of the colon, which retards advancement of the instrument. Colonoscopy can be challenging with old instruments that have lost native stiffness and become less responsive to torquing.A new intraluminal stiffening device has become available in two grades of stiffness. However, there is no published evidence of its effectiveness. This randomized, controlled trial was designed to determine the effectiveness of the stiffening wires in improving cecal intubation rate and time following routine application. A secondary analysis determines effectiveness of application only after intractable failure with the unaided colonoscope.The colonoscope tested was an Olympus CF-100TL, approximately fifteen years old. Patients were randomly assigned to the unaided colonoscope or the standard or firm wire introduced routinely on entry into transverse colon. Each phase of colonoscopy was timed. Failure to advance the colonoscope for 5?minutes (despite usual manipulations to minimize looping) required switching to another intervention according to a prescribed methodology and the originally assigned intervention was recorded as failed.The study was terminated after accrual of 112 participants (target sample size 480) because the colonoscope required repairs (no damage attributable to stiffening wires) which would have been uneconomical. There were no statistically significant differences between per-protocol cecal intubation rates (81.1, 71.1 and 70.3 percent respectively), a finding which persisted after multiple imputation for a virtual sample size of 480. Similarly, there were no statistically significant differences between per-protocol cecal intubation times (15, 16.2 and 13.9?minutes). However, a statistically significant improvement in cecal intubation rate (from 81.1% to 97.3%, P?=?0.0313) was achieved when the wires were applied after intractable failure of the unaided colonoscope in the first intervention group.Routine application of either stiffening wire does not improve caecal intubation rate nor time compared to the unaided colonoscope. However, application of the stiffening wires after intractable failure of the unaided colonoscope enabled a statistically significant improvement in cecal intubation rate.clinicaltrials.gov Identifier: NCT01115010.

SUBMITTER: East JM

PROVIDER: S-EPMC3571927 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial.

East Jeffrey M JM

BMC research notes 20130204

<h4>Background</h4>Colonoscopes are designed with balance between flexibility, required to negotiate angulations, and stiffness, required to counteract the propensity for looping in unfixed sections of the colon, which retards advancement of the instrument. Colonoscopy can be challenging with old instruments that have lost native stiffness and become less responsive to torquing.A new intraluminal stiffening device has become available in two grades of stiffness. However, there is no published ev ...[more]

PMID: 23379922

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Project description:ObjectivesTo develop a novel laryngoscope device capable of dynamically measuring force and torque measurements in real-time during intubation and to explore the efficacy of such a device through a face validation simulation.MethodsThe torque sensor laryngoscope is designed for use during intubation and is modeled after a standard, single-use plastic laryngoscope. After device calibration, a face validation study was performed with intubation experts in the field. Quantitative data (intubation force metrics) and qualitative data (expert feedback on the device) were collected from three intubations using a Mac blade and three intubations with the Miller blade.ResultsThree experts (two anesthesiologists and one otolaryngologist) participated in the study. The mean maximum force exerted with the Mac blade was 24.5 N (95% confidence interval [CI], 22.3-26.8). The average force exerted was 13.6 N (95% CI, 11.7-15.5). The average total suspension time was 13.1 s (95% CI, 10.4-15.8). The average total impulse was 164.6 N·s (95% CI, 147.9-181.4). The mean maximum force exerted with the Miller blade was 31.6 N (95% CI, 26.4-36.8). The average force exerted was 15.8 N (95% CI, 13.8-17.9). The average total suspension time was 11.3 s (95% CI, 9.9-12.6). The average total impulse was 216.2 N·s (95% CI, 186.5-245.9). The mean maximum force (p = .0265) and total impulse (p = .009) were significantly higher in the Miller blade trials than in the Mac blade trials. Survey results found that this device, while bulky, intubated similarly to standard-use models and has potential as an intubation teaching tool.ConclusionThe torque sensor laryngoscope can measure and display real-time intubation force metrics for multiple laryngoscope blades. Initial validation studies showed a significantly lower maximum force and total impulse when intubating with the Mac blade than with the Miller blade. Face validation survey results were positive and suggested the potential for this device as a teaching tool.Level of evidenceLevel 5.

Dataset Information

Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial.

Publications

Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial.

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