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Completed

NCT Number: NCT06676865

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mongi Slim University Hospital

Tunis, 2046, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

the palm print test

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.

Primary outcomes

  1. Difficult laryngoscopy

    Time frame: after induction of anesthesia and during laryngoscopy

    Cormack and Lehane graded I to IV. Grades III or IV showed difficult laryngoscopy.

Secondary outcomes

  1. Difficult intubation

    Time frame: at induction of anesthesia

    Need of more than 2 laryngoscopies to intubate the patient

Sponsors and collaborators

Lead sponsor

Mongi Slim Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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