An interventional study of Airway management in Obesity Difficult Airway Airway Management, sponsored by Uniwersytet Radomski im. Kazimierza Pułaskiego. Enrolling by invitation at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Uniwersytet Radomski im. Kazimierza Pułaskiego · Not applicable, Interventional, and Treatment
Among 11 studies in Obesity, Morbid with a site in Poland — 2 open to participants now, 2 under way, none of them phase 3. Obesity, Morbid · Poland.
Among the 11 studies in Obesity, Morbid with a site in Poland, this one is the only one that started in 2026, is one of 6 with no phase, and was the 11th registered.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
Browse Obesity, Morbid studies →2 of the 11 studies in Obesity, Morbid with a site in Poland are open now. Recruiting first, the newest first:
Jagiellonian University · Sites in Poland
A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →
Of the 109 Obesity, Morbid studies recruiting now, 21 (19%) set no upper age limit and 83 (76%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 100 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Median enrollment 100 across the 7 interventional studies, 75 across the 4 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
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None of the 11 has an industry lead sponsor. The 5 most frequent:
Uniwersytet Radomski im. Kazimierza Pułaskiego is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Uniwersytet Radomski im. Kazimierza Pułaskiego has 1 study filed under Obesity, Morbid — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Obesity, Morbid with a site in Poland, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study will evaluate four videolaryngoscopes used for intubation of extremely obese (class 3 obesity) patients scheduled for bariatric surgery. One hundred adult patients will be scheduled for an elective sleeve gastrectomy at the Mazowiecki Szpital Specjalistyczny in Radom, Poland. All patients will receive premedication with 300 mg pregabalin 30 minutes before the start of anaesthesia. An extended monitoring will be applied. This consists of ECG, IBP (invasive blood pressure), SpO2, TOF (train-of-four), entropy and volatile anaesthetic concentration. All patients will be placed in a ramped position (HELP - Head-elevated Laryngoscopy Position) and will be pre-oxygenated with FiO2 1.0 for three minutes prior to induction. A standardised local protocol of opioid-free anaesthesia for bariatric patients will be utilised. Prior to proper induction of anaesthesia, IV infusions of 1% lidocaine and dexmedetomidine 10 µg ml-1 will be started. This will be followed by induction with IV propofol (200 mg) and ketamine (50 mg). Rocuronium (100 mg) will be used as a neuromuscular blocking agent. Adequate neuromuscular block will be confirmed and controlled throughout the procedure with TOF Watch (Organon, Dublin, Ireland). A cuffed, size 8.0 tracheal tube with stylet (Sumi, Sulejówek, Poland) will be used for intubation. A single-use hyperangulated blade will be used in all studied devices. Correct placement of the tracheal tube will be confirmed by videolaryngoscopy, capnography and chest auscultation. All patients will be anaesthetised by experienced consultant anaesthetists with over 10 years of clinical practice after completion of specialist training. Furthermore, all anaesthetists participating in the study will be trained with all VLs used until they feel competent. Only two intubation attempts with a studied videolaryngoscope will be allowed. A single attempt will be limited to 60 seconds. A failure is defined as an attempt which lasted more than 60 seconds, when saturation dropped below 90%, after two unsuccessful attempts, when airway injury or bronchospasm occurred. A single-digit number will be allocated to each of the studied videolaryngoscopes: 1 for the C-MAC PM, 2 for the McGrath MAC, 3 for the VisionPro and 4 for the AceScope. A single sheet of paper containing printed number will be placed in an opaque envelope. Then they will be assigned to the participating anaesthetist by computer-generated randomization. The SPSS 29.0 software (IBM, Armonk, NY, USA) will be used for allocation. Furthermore, patients will be blinded to randomization.
This study will evaluate four videolaryngoscopes used for intubation of extremely obese (class 3 obesity) patients scheduled for bariatric surgery. One hundred adult patients will be scheduled for an elective sleeve gastrectomy at the Mazowiecki Szpital Specjalistyczny in Radom, Poland. All patients will receive premedication with 300 mg pregabalin 30 minutes before the start of anaesthesia. An extended monitoring will be applied. This consists of ECG, IBP (invasive blood pressure), SpO2, TOF (train-of-four), entropy and volatile anaesthetic concentration. All patients will be placed in a ramped position (HELP - Head-elevated Laryngoscopy Position) and will be pre-oxygenated with FiO2 1.0 for three minutes prior to induction. A standardised local protocol of opioid-free anaesthesia for bariatric patients will be utilised. Prior to proper induction of anaesthesia, IV infusions of 1% lidocaine and dexmedetomidine 10 µg ml-1 will be started. This will be followed by induction with IV propofol (200 mg) and ketamine (50 mg). Rocuronium (100 mg) will be used as a neuromuscular blocking agent. Adequate neuromuscular block will be confirmed and controlled throughout the procedure with TOF Watch (Organon, Dublin, Ireland). A cuffed, size 8.0 tracheal tube with stylet (Sumi, Sulejówek, Poland) will be used for intubation. A single-use hyperangulated blade will be used in all studied devices. Correct placement of the tracheal tube will be confirmed by videolaryngoscopy, capnography and chest auscultation. All patients will be anaesthetised by experienced consultant anaesthetists with over 10 years of clinical practice after completion of specialist training. Furthermore, all anaesthetists participating in the study will be trained with all VLs used until they feel competent. Only two intubation attempts with a studied videolaryngoscope will be allowed. A single attempt will be limited to 60 seconds. A failure is defined as an attempt which lasted more than 60 seconds, when saturation dropped below 90%, after two unsuccessful attempts, when airway injury or bronchospasm occurred. A single-digit number will be allocated to each of the studied videolaryngoscopes: 1 for the C-MAC PM, 2 for the McGrath MAC, 3 for the VisionPro and 4 for the AceScope. A single sheet of paper containing printed number will be placed in an opaque envelope. Then they will be assigned to the participating anaesthetist by computer-generated randomization. The SPSS 29.0 software (IBM, Armonk, NY, USA) will be used for allocation. Furthermore, patients will be blinded to randomization.
Collected data will be analysed using Statistica 14.0 (TIBCO Software, Palo Alto, CA, USA) and Microsoft Office Excel 2021 spreadsheet (Microsoft, Redmond, WA, USA). The Wilcoxon signed-rank test and the paired Student t-test will be used for data analysis. Continuous variables will be presented either as mean ± SD (standard deviation) or median (IQR - interquartile range) for non-normally distributed data. The Kolmogorov-Smirnov test determines whether the analysed variables match the characteristics of a normal distribution. The investigators assumed that the overall success rate of intubation in obese patients would be 90% (α = 0.05, 2-sided, β = 0.1, 95% CI). The calculated sample size requires 95 participants and the final adjusted sample size will be 100 patients to compensate for dropouts. A p-value of less than 0.05 (p \< 0.05) is considered statistically significant.
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Exclusion Criteria:
Device: Airway management
Device: Airway management
Device: Airway management
Device: Airway management
Device used for intubation
First-attempt success
This is the percentage of successful tracheal tube placement at the first attempt.
Time frame: From date of randomization until the date of first documented progression, assessed up to 10 months
Intubation time
The intubation time is defined as the time from picking up the videolaryngoscope until the correct placement of the tracheal tube has been confirmed by capnography. A stop watch of a mobile phone (Apple, Cupertino, CA, USA) will be used to measure the intubation time.
Time frame: From date of randomization until the date of first documented progression, assessed up to 10 months
Image quality
It will be evaluated using the Numerical Rating Scale (NRS). This is an eleven-point scale, i.e. from 0 to 10. The NRS score of 0 indicates blurred, difficult to read picture and 10 denotes sharp with adequate colours, top quality image.
Time frame: From date of randomization until the date of first documented progression, assessed up to 10 months
User-friendliness of the device used
It will be evaluated using the Numerical Rating Scale (NRS). This is an eleven-point scale, i.e. from 0 to 10, and regarding the ease-of-use 0 denotes a very difficult and complicated to use device while 10 corresponds to an user-friendly equipment.
Time frame: From date of randomization until the date of first documented progression, assessed up to 10 months
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.
Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 2 months is below that.
Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Uniwersytet Radomski im. Kazimierza Pułaskiego