Endotracheal tube-mounted camera-assisted intubation versus conventional intubation in intensive care: a prospective, randomised trial (VivaITN).
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SUBMITTER: Grensemann J
PROVIDER: S-EPMC6151025 | biostudies-literature | 2018 Sep
REPOSITORIES: biostudies-literature
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Project description:Background: Tracheal intubation in patients with an expected difficult airway may be facilitated by videolaryngoscopy (VL). The VL viewing axis angle is specified by the blade shape and visualization of the larynx may fail if the angle does not meet anatomy of the patient. A tube with an integrated camera at its tip (VST, VivaSight-SL) may be advantageous due to its adjustable viewing axis by means of angulating an included stylet. Methods: With ethics approval, we studied the VST vs. VL in a prospective non-inferiority trial using end-tidal oxygen fractions (etO2) after intubation, first-attempt success rates (FAS), visualization assessed by the percentage of glottis opening (POGO) scale, and time to intubation (TTI) as outcome parameters. Results: In this study, 48 patients with a predicted difficult airway were randomized 1:1 to intubation with VST or VL. Concerning oxygenation, the VST was non-inferior to VL with etO2 of 0.79 ± 0.08 (95% CIs: 0.75-0.82) vs. 0.81 ± 0.06 (0.79-0.84) for the VL group, mean difference 0.02 (-0.07 to 0.02), p = 0.234. FAS was 79% for VST and 88% for VL (p = 0.449). POGO was 89 ± 21% in the VST-group and 60 ± 36% in the VL group, p = 0.002. TTI was 100 ± 57 s in the VST group and 68 ± 65 s in the VL group (p = 0.079). TTI with one attempt was 84 ± 31 s vs. 49 ± 14 s, p < 0.001. Conclusion: In patients with difficult airways, tracheal intubation with the VST is feasible without negative impact on oxygenation, improves visualization but prolongs intubation. The VST deserves further study to identify patients that might benefit from intubation with VST.
| S-EPMC8714897 | biostudies-literature
Project description:BackgroundData on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (with both Macintosh-shaped and hyperangulated blades) is at least equal to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure.MethodsIn this randomized, controlled, three-armed parallel group design, multi-centre trial, a total of more than 2500 adult patients scheduled for perioperative endotracheal intubation will be randomized. In equally large arms, video-assisted laryngoscopy with a Macintosh-shaped or a hyperangulated blade will be compared to the standard of care (direct laryngoscopy with Macintosh blade). In a pre-defined hierarchical analysis, we will test the primary outcome for non-inferiority first. If this goal should be met, the design and projected statistical power also allow for subsequent testing for superiority of one of the interventions. Various secondary outcomes will account for patient safety considerations as well as human factors interactions within the provider team and will allow for further exploratory data analysis and hypothesis generation.DiscussionThis randomized controlled trial will provide a solid base of data in a field where reliable evidence is of major clinical importance. With thousands of endotracheal intubations performed every day in operating rooms around the world, every bit of performance improvement translates into increased patient safety and comfort and may eventually prevent significant burden of disease. Therefore, we feel confident that a large trial has the potential to considerably benefit patients and anaesthetists alike.Trial registrationClincalTrials.gov NCT05228288.Protocol version1.1, November 15, 2021.
| S-EPMC10111720 | biostudies-literature
Project description:BackgroundPercutaneous dilatational tracheostomy (PDT) in critically ill patients often involves bronchoscopic optical guidance. However, this procedure is not without disadvantages. Therefore, we aimed to study a recently introduced endotracheal tube-mounted camera (VivaSightTM-SL tube [VST]; ETView, Misgav, Israel) for guiding PDT.MethodsThis was a randomized controlled trial involving 46 critically ill patients who received PDT using optical guidance with a VST or with bronchoscopy. The primary outcome measure was visualization of the tracheal structures (i.e., identification and monitoring of the thyroid, cricoid, and tracheal cartilage and the posterior wall) rated on 4-point Likert scales. Secondary measures were the quality of ventilation (before puncture and during the tracheostomy procedure rated on 4-point Likert scales) and blood gases sampled at standardized time points.ResultsThe mean ratings for visualization (lower values better; values given for per-protocol analysis) were 5.4 (95% CI 4.5-6.3) for the VST group and 4.0 (95% CI 4.0-4.0) for the bronchoscopy group (p < 0.001). Mean ventilation ratings were 2.5 (95% CI 2.1-2.9) for VST and 5.0 (95% CI 4.4-5.7) for bronchoscopy (p < 0.001). Arterial carbon dioxide increased to 5.9 (95% CI 5.4-6.5) kPa in the VST group vs. 8.3 (95% CI 7.2-9.5) kPa in the bronchoscopy group (p < 0.001), and pH decreased to 7.40 (95% CI 7.36-7.43) in the VST group vs. 7.26 (95% CI 7.22-7.30) in the bronchoscopy group (p < 0.001), at the end of the intervention.ConclusionsVisualization of PDT with the VST is not noninferior to guidance by bronchoscopy. Ventilation is superior with less hypercarbia with the VST. Because visualization is not a prerequisite for PDT, patients requiring stable ventilation with normocarbia may benefit from PDT with the VST.Trial registrationClinicalTrials.gov, NCT02861001 . Registered on 13 June 2016.
| S-EPMC5747130 | biostudies-literature
Project description:IntroductionTracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established.Methods and analysisThe endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.Ethics and disseminationThe study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.Trial registration detailsClinicalTrials.gov Identifier: NCT04079387; Pre-results.
| S-EPMC7542923 | biostudies-literature
Project description:PurposeThe effect of the routine use of a stylet during tracheal intubation on first-attempt intubation success is unclear. We hypothesised that the first-attempt intubation success rate would be higher with tracheal tube + stylet than with tracheal tube alone.MethodsIn this multicentre randomised controlled trial, conducted in 32 intensive care units, we randomly assigned patients to tracheal tube + stylet or tracheal tube alone (i.e. without stylet). The primary outcome was the proportion of patients with first-attempt intubation success. The secondary outcome was the proportion of patients with complications related to tracheal intubation. Serious adverse events, i.e., traumatic injuries related to tracheal intubation, were evaluated.ResultsA total of 999 patients were included in the modified intention-to-treat analysis: 501 (50%) to tracheal tube + stylet and 498 (50%) to tracheal tube alone. First-attempt intubation success occurred in 392 patients (78.2%) in the tracheal tube + stylet group and in 356 (71.5%) in the tracheal tube alone group (absolute risk difference, 6.7; 95%CI 1.4-12.1; relative risk, 1.10; 95%CI 1.02-1.18; P = 0.01). A total of 194 patients (38.7%) in the tracheal tube + stylet group had complications related to tracheal intubation, as compared with 200 patients (40.2%) in the tracheal tube alone group (absolute risk difference, - 1.5; 95%CI - 7.5 to 4.6; relative risk, 0.96; 95%CI 0.83-1.12; P = 0.64). The incidence of serious adverse events was 4.0% and 3.6%, respectively (absolute risk difference, 0.4; 95%CI, - 2.0 to 2.8; relative risk, 1.10; 95%CI 0.59-2.06. P = 0.76).ConclusionsAmong critically ill adults undergoing tracheal intubation, using a stylet improves first-attempt intubation success.
| S-EPMC8144872 | biostudies-literature
Project description:BackgroundThis study investigated the feasibility of video-assisted thoracic surgery (VATS) performed under two-lung ventilation (TLV) and single-lumen endotracheal tube (SLET) intubation in patients with spontaneous pneumothorax.MethodsFrom January 2016 to December 2019, 344 patients who underwent VATS with spontaneous pneumothorax, whether primary or secondary, were enrolled. The surgery was performed through TLV using SLET intubation or one-lung ventilation (OLV) using double-lumen endotracheal tube (DLET) intubation. Patient data were collected retrospectively from medical records and compared with an emphasis on the time required for anesthesia and surgery.ResultsThe average anesthesia time was 72.6±17.8 min for TLV and 89.9±24.3 min for OLV (P<0.001). The average operating time was 42.1±16.2 min for TLV and 54.7±23.8 min for OLV (P<0.001). The average time from the onset of anesthesia to incision was 23.6±7.0 min for TLV and 27.6±9.5 min for OLV (P<0.001). There was no case of conversion to OLV using DLET intubation during surgery with TLV using SLET intubation. Removal of the chest tube took 1.6±1.1 days for the TLV group and 2.3±3.6 days for the OLV group (P=0.017). Patients were discharged at 2.7±1.2 days after surgery for the TLV group and 3.2±2.3 days after surgery for the OLV group (P=0.009).ConclusionsTLV using SLET intubation could shorten the time required for anesthesia-related procedures and surgery. In addition, it can be a beneficial surgical and anesthetic option for pneumothorax.
| S-EPMC10407499 | biostudies-literature
Project description:BackgroundLidocaine (LDC) is a local anesthetic widely used to relieve intubation-related airway responses. However, low drug concentration and short effective duration of LDC is inadequate to provide a satisfactory anesthetic effect on the surface of the airway. The present study sought to develop a LDC-delivery endotracheal tube (ETT) to achieve high local drug concentration and sustained drug release with the aim of attenuating an intubation-related airway response.MethodsETTs and polyvinyl chloride (PVC) discs were coated with different molecular weight (MW) poly lactic-co-glycolic acid (PLGA: 50/50; MW: 3,000, 6,000, and 10,000) loaded with LDC by airbrush spray. The morphology of LDC-eluting coatings was analyzed using scanning electron microscopy. In vitro drug release was determined by ultraviolet spectrophotometer. An in vivo study was performed to investigate the differences in plasma LDC concentration, intubation tolerance, and tracheal tissue injury in rabbits undergoing intubation of blank, LDC-spray, or LDC-coated ETTs.ResultsApproximate 5 mg/cm2 coatings (containing 2.5 mg/cm2 LDC) were deposited onto the PVC discs and ETTs. While even distribution and smooth surfaces were generated in PLGA3000 + LDC and PLGA6000 + LDC coatings, PLGA10000 + LDC formed uneven and gullied coatings. Burst release within the first 4 h and sustained release for at least 5 days was achieved in vitro in PLGA + LDC coatings and the in vivo study demonstrated higher plasma LDC concentration and longer drug release duration in LDC-coated ETTs compared with LDC-spray. LDC-coated ETTs significantly improved intubation tolerance in rabbits, as measured by less general anesthetic consumption and longer tube tolerance duration in contrast to blank ETTs with or without LDC spray. Histology assessment showed less mucosal edema area in the PLGA3000 + LDC and PLGA6000 + LDC groups compared to the control, LDC-spray, and PLGA10000 + LDC groups. Among the different MW PLGAs, PLGA6000 presented optimal morphological characteristics, drug release, and anesthetic effect.ConclusionsETTs coated with PLGA + LDC effectively attenuate an intubation-related airway response via increasing local drug concentration and extending drug action duration, which demonstrates a potential therapeutic benefit for patients undergoing intubation.
| S-EPMC8184491 | biostudies-literature
Project description:BackgroundAirway management is a crucial skill essential to paramedics and personnel working in Emergency Medical Services and Emergency Departments: Lack of practice, a difficult airway, or a trauma situation may limit the ability of paramedics to perform direct laryngoscopy during cardiopulmonary resuscitation. Videoscope devices are alternatives for airway management in these situations. The ETView VivaSight SL (ETView; ETView Ltd., Misgav, Israel) is a new, single-lumen airway tube with an integrated high-resolution imaging camera. To assess if the ETView VivaSight SL can be a superior alternative to a standard endotracheal tube for intubation in an adult cadaver model, both during and without simulated CPR.MethodsETView VivaSight SL tube was investigated via an interventional, randomized, crossover, cadaver study. A total of 52 paramedics participated in the intubation of human cadavers in three different scenarios: a normal airway at rest without concomitant chest compression (CC) (scenario A), a normal airway with uninterrupted CC (scenario B) and manual in-line stabilization (scenario C). Time and rate of success for intubation, the glottic view scale, and ease-of-use of ETView vs. sETT intubation were assessed for each emergency scenario.ResultsThe median time to intubation using ETView vs. sETT was compared for each of the aforementioned scenarios. For scenario A, time to first ventilation was achieved fastest for ETView, 19.5 [IQR, 16.5-22] sec, when compared to that of sETT at 21.5 [IQR, 20-25] sec (p = .013). In scenario B, the time for intubation using ETView was 21 [IQR, 18.5-24.5] sec (p < .001) and sETT was 27 [IQR, 24.5-31.5] sec. Time to first ventilation for scenario C was 23.5 [IQR, 19-25.5] sec for the ETView and 42.5 [IQR, 35-49.5] sec for sETT.ConclusionsIn normal airways and situations with continuous chest compressions, the success rate for intubation of cadavers and the time to ventilation were improved with the ETView. The time to glottis view, tube insertion, and cuff block were all found to be shorter with the ETView.Trial registrationclinicaltrials.gov Identifier: NCT02733536.
| S-EPMC5591099 | biostudies-literature
Project description:ObjectiveTo determine which bedside method of detecting inadvertent endobronchial intubation in adults has the highest sensitivity and specificity.DesignProspective randomised blinded study.SettingDepartment of anaesthesia in tertiary academic hospital.Participants160 consecutive patients (American Society of Anesthesiologists category I or II) aged 19-75 scheduled for elective gynaecological or urological surgery.InterventionsPatients were randomly assigned to eight study groups. In four groups, an endotracheal tube was fibreoptically positioned 2.5-4.0 cm above the carina, whereas in the other four groups the tube was positioned in the right mainstem bronchus. The four groups differed in the bedside test used to verify the position of the endotracheal tube. To determine whether the tube was properly positioned in the trachea, in each patient first year residents and experienced anaesthetists were randomly assigned to independently perform bilateral auscultation of the chest (auscultation); observation and palpation of symmetrical chest movements (observation); estimation of the position of the tube by the insertion depth (tube depth); or a combination of all three (all three).Main outcome measuresCorrect and incorrect judgments of endotracheal tube position.Results160 patients underwent 320 observations by experienced and inexperienced anaesthetists. First year residents missed endobronchial intubation by auscultation in 55% of cases and performed significantly worse than experienced anaesthetists with this bedside test (odds ratio 10.0, 95% confidence interval 1.4 to 434). With a sensitivity of 88% (95% confidence interval 75% to 100%) and 100%, respectively, tube depth and the three tests combined were significantly more sensitive for detecting endobronchial intubation than auscultation (65%, 49% to 81%) or observation(43%, 25% to 60%) (P<0.001). The four tested methods had the same specificity for ruling out endobronchial intubation (that is, confirming correct tracheal intubation). The average correct tube insertion depth was 21 cm in women and 23 cm in men. By inserting the tube to these distances, however, the distal tip of the tube was less than 2.5 cm away from the carina (the recommended safety distance, to prevent inadvertent endobronchial intubation with changes in the position of the head in intubated patients) in 20% (24/118) of women and 18% (7/42) of men. Therefore optimal tube insertion depth was considered to be 20 cm in women and 22 cm in men.ConclusionLess experienced clinicians should rely more on tube insertion depth than on auscultation to detect inadvertent endobronchial intubation. But even experienced physicians will benefit from inserting tubes to 20-21 cm in women and 22-23 cm in men, especially when high ambient noise precludes accurate auscultation (such as in emergency situations or helicopter transport). The highest sensitivity and specificity for ruling out endobronchial intubation, however, is achieved by combining tube depth, auscultation of the lungs, and observation of symmetrical chest movements.Trial registrationNCT01232166.
| S-EPMC2977961 | biostudies-literature
Project description:ObjectiveAdvancement of the endotracheal tube through a fibreoptic scope can sometimes prove to be challenging in obese patients. The Parker Flex-Tip endotracheal tube was developed with a curved and tapered distal tip to facilitate easier placement in the trachea. This study examined the use of the Parker Flex-Tip tube as compared to standard endotracheal tubes in patients with a body mass index of 30 or greater.MethodsSixty patients undergoing surgery requiring general anaesthesia were randomised into two groups. Using the fibreoptic scope, one group was intubated with the Parker Flex-Tip tube and the other group with a standard polyvinyl Portex tube. The time for intubation and the number of attempts required to place the endotracheal tube were measured and recorded.ResultsUsing the Mann-Whitney U rank sum test, the median time needed for intubation with the two types of endotracheal tubes did not show a significant difference. The chi-square analyses were conducted for the number of attempts needed to place the endotracheal tubes, which also did not demonstrate any significant difference.ConclusionsParker Flex-Tip endotracheal tube was not superior to the standard endotracheal tubes for fibreoptic intubation in obese patients.
| S-EPMC6756311 | biostudies-literature