NCT06676865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
Last Updated

November 6, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 22, 2024

Last Update Submit

November 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difficult laryngoscopy

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

    after induction of anesthesia and during laryngoscopy

Secondary Outcomes (1)

  • Difficult intubation

    at induction of anesthesia

Study Arms (1)

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

Interventions

the palm print testDIAGNOSTIC_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.

adult Diabetic patients scheduled for surgery under general anesthesia.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim University Hospital

Tunis, 2046, Tunisia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 22, 2024

First Posted

November 6, 2024

Study Start

December 1, 2023

Primary Completion

May 31, 2024

Study Completion

July 31, 2024

Last Updated

November 6, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations