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

NCT ID: NCT06676865

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-07-31

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.

Conditions

Difficult Laryngoscopy; Diabetes; Preoperative Period

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

the palm print test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mongi Slim Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mhamed Sami Mebazaa

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mongi Slim University Hospital

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

Palm print test

Identifier Type: -

Identifier Source: org_study_id