An observational study in Difficult Laryngoscopy, Diabetes and Preoperative Period, sponsored by Mongi Slim Hospital. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Mongi Slim Hospital · Observational
The investigators assessed upper airway management at the pre-anaesthetic consultation using the usual clinical criteria. On the day before surgery, diabetic patients were assessed for the palm print sign to predict difficult laryngoscopy. After induction of anesthesia, laryngoscopy was performed with a Macintosh metal laryngoscope blade. At this stage of the study, patients were categorized into two groups: difficult and easy laryngoscopy.
During pre-anesthesia consultation, all participants were assessed for airway conditions using usual clinical tests (Mallampati classification, Thyromental distance, mouth-opening test, upper lip biting test (ULBT), Head extension and Prayer sign). Demographic characteristics, diabetes duration, Blood glucose regulation and diabetes-related complications were also recorded.
On the day before surgery, patients were assessed for the palm print sign during preoperative evaluation rounds. On the day of surgery, after an intravenous line (IV) and complete monitoring, induction of anesthesia was initiated, and a muscle relaxant was used to facilitate intubation. Laryngoscopy was performed with a Macintosh metal laryngoscope blade by an anesthesiologist who had more than 2 years of intubation experience. McGrath® videolaryngoscope, McCoy laryngoscope, LMA Fastrack®, or i-gel® airway were kept ready for emergency situations. At this stage of the study, patients were categorized into two groups: difficult and easy laryngoscopy.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 150 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Mongi Slim Hospital is the lead sponsor of 38 studies on the registry; 5 are open to participants now.
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Were included adult patients with diabetes mellitus undergoing surgery under general anesthésia with intubation.
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Exclusion Criteria:
Were included patients with known cases of diabetes mellitus, aged more than 18 years, undergoing surgery under general anesthesia with endotracheal intubation. This study excluded patients with physical or intellectual disabilities preventing cooperation, Malformations, trauma, tumors, or infections of the maxillofacial region and upper airways, a history of burns or cervicofacial irradiation, and neurosurgical conditions causing temporomandibular pseudoankylosis. Additional exclusions included patients with conditions causing hand joint stiffness (e.g., carpal tunnel syndrome, Dupuytren's disease, scleroderma, rheumatoid arthritis), restricted cervical mobility (due to osteoarthritis, ankylosing spondylitis, or cervical trauma), a history of difficult intubation as well as pregnancy (including up to six weeks postpartum)
Diagnostic Test: the palm print test
The patient's dominant hand was pressed firmly against a blue ink pad, then onto a white sheet of paper without applying body weight. The palm prints were scored as follows: * Grade 0: All phalangeal areas visible * Grade 1: Deficiency in the interphalangeal areas of the 4th and 5th digits * Grade 2: Deficiency in the interphalangeal areas of the 2nd to 5th digits * Grade 3: Only the tips of the digits visible The palm print test was scored from 0 to 3. Grades 2 and 3 were considered indicators of difficult intubation.
Difficult laryngoscopy
Cormack and Lehane graded I to IV. Grades III or IV showed difficult laryngoscopy.
Time frame: after induction of anesthesia and during laryngoscopy
Difficult intubation
Need of more than 2 laryngoscopies to intubate the patient
Time frame: at induction of anesthesia
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in May 2024, 5 months.
Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's 5 months is below that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Mongi Slim Hospital