Preoperative Prediction of Difficult Laryngoscopy in Diabetic Patients: Importance of the Palm Print Test

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Preoperative Period; Difficult Laryngoscopy
• Intervention / Treatment: Diagnostic test: the palm print test

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 2046
    • Mongi Slim University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Were included adult patients with diabetes mellitus undergoing surgery under general anesthésia with intubation.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

adult Diabetic patients scheduled for surgery under general anesthesia.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult laryngoscopy	Cormack and Lehane graded I to IV. Grades III or IV showed difficult laryngoscopy.	after induction of anesthesia and during laryngoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult intubation	Need of more than 2 laryngoscopies to intubate the patient	at induction of anesthesia

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Palm print test

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No