Clinical trial NCT06676865: Preoperative Prediction of Difficult Laryngoscopy in Diabetic Patients: Importance of the Palm Print Test
Official title: Preoperative Prediction of Difficult Laryngoscopy in Diabetic Patients: Importance of the Palm Print Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Laryngoscopy
Diabetes
Preoperative Period
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Were included adult patients with diabetes mellitus undergoing surgery under general anesthésia with intubation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus
* aged more than 18 years
* undergoing surgery under general anesthesia with endotracheal intubation.

Exclusion Criteria:

* 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
* neurosurgical conditions causing temporomandibular pseudoankylosis.
* 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
* pregnancy (including up to six weeks postpartum)

Primary outcomes:
measure: Difficult laryngoscopy
timeFrame: after induction of anesthesia and during laryngoscopy
Secondary outcomes:
measure: Difficult intubation
timeFrame: at induction of anesthesia
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim University Hospital
Study officials:
References: