Difficult LaryngoscopyNCT06676865
Preoperative Prediction of Difficult Laryngoscopy in Diabetic Patients: Importance of the Palm Print Test
An observational study of Difficult Laryngoscopy and Diabetes, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Laryngoscopy, Diabetes, Preoperative Period
- What is being tested?
- the palm print test
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Were included adult patients with diabetes mellitus undergoing surgery under general anesthésia with intubation.
Who may be able to join
- diabetes mellitus
- aged more than 18 years
- undergoing surgery under general anesthesia with endotracheal intubation.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- the palm print test
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: the palm print test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult laryngoscopy
Cormack and Lehane graded I to IV. Grades III or IV showed difficult laryngoscopy.
Measured: after induction of anesthesia and during laryngoscopy
Secondary outcomes (1)
Difficult intubation
Need of more than 2 laryngoscopies to intubate the patient
Measured: at induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Dec 2023
- Primary completion31 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult LaryngoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676865
- Sponsor's protocol ID
- Palm print test
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Prediction of Difficult Laryngoscopy in Diabetic Patients: Importance of the Palm Print Test
- ClinicalTrials.gov ID
- NCT06676865
- Acronym / sponsor ID
- Palm print test
- Conditions
- Difficult Laryngoscopy, Diabetes, Preoperative Period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult Diabetic patients scheduled for surgery under general anesthesia. | – | Diagnostic Test: the palm print testWere 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Were included adult patients with diabetes mellitus undergoing surgery under general anesthésia with intubation.
Key inclusion criteria (3 listed)
- diabetes mellitus
- aged more than 18 years
- undergoing surgery under general anesthesia with endotracheal intubation.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the palm print testThe 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. | Diagnostic test | adult Diabetic patients scheduled for surgery under general anesthesia. |
Primary outcome
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.
1 secondary outcome
Difficult intubation
Time frame: at induction of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Laryngoscopy and Diabetes, run by Mongi Slim Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficult laryngoscopy (time frame: after induction of anesthesia and during laryngoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.