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General Anesthesia; Tracheal IntubationWWINCT07894692

Association of WWI With Difficult Intubation

An observational study of General Anesthesia; Tracheal Intubation, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Difficult intubation remains a clinically significant challenge in anesthetic practice, particularly among patients with obesity and altered body composition. Traditional predictors such as BMI and neck circumference have limitations in accurately identifying at-risk patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
General Anesthesia; Tracheal Intubation
What is being tested?
Weight, Height, BMI, Waist circumference, WWI, Neck circumference, Mallampati score, Sternomental distance, EGRI score, BMV grade Cormack-Lehane grade,Number of attempts Use of adjunts
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Nov 2025to 25 Mar 2026
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: patients scheduled for any surgical procedures who need endotracheal intubation to conduct GA.

Who may be able to join

  • Patients scheduled for elective surgical procedures requiring endotracheal intubation under general anesthesia using direct laryngoscopy.

Who cannot join

  • Patients' refusal.
  • Patients with a history of difficult intubation.
  • Patients with obstructive sleep apnea.
  • Emergency surgeries
  • Patients with known or suspected airway pathology (e.g., tumors, trauma)
  • Syndrome-related difficult airways.
Show all 12Show fewer
  • Temporomandibular joint (TMJ) ankylosis.
  • Traumatic facial injuries.
  • Facial burns.
  • Pregnant.
  • Conditions with reduced functional residual reserve e.g. moderate to severe ascites or preoperative SpO2 at room air <95%.
  • Cervical spine diseases

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Alainy Hospital

    Cairo, Almanial, 12211

Other trials in Egypt

About this study

Official title: Association of Weight-Adjusted Waist Index With Difficult Intubation: A Prospective Observational Cohort Study

Difficult intubation remains a clinically significant challenge in anesthetic practice, particularly among patients with obesity and altered body composition. Traditional predictors such as BMI and neck circumference have limitations in accurately identifying at-risk patients.

The weight-adjusted waist circumference index (WWI), introduced by Park et al., provides a measure of age-related changes in body composition, including loss of muscle mass and retention or increase in fat mass. Some researchers have proposed a cut-off value of 10.4 cm/√kg in men and 10.5 cm/√kg in women to identify unhealthy body composition. WWI provides a clearer picture of fat distribution, especially in individuals with varying body sizes, making it a more reliable tool for assessing health risks related to abdominal fat. After a thorough literature review, studies correlating WWI with DI remain limited. Therefore, the present study aimed to assess the correlation between WWI and DI in 50 patients scheduled for elective surgeries requiring endotracheal intubation under direct laryngoscopy.

Read the detailed description

This prospective observational cohort study was conducted at Kasr Alainy Hospitals, Cairo University, Egypt. The study protocol was approved by the Anesthesia Department Research Committee and the Kasr Alainy Research and Ethics Committee. Written informed consent was obtained from all participants prior to enrollment. All procedures followed the ethical standards of the institutional research committee and the 1964 Helsinki declaration and its later amendments.

  1. Study design:

This study was designed as a cohort study, conducted to evaluate the association between the weight-adjusted waist index (WWI) and the incidence of difficult tracheal intubation.

II. Study population:

Adult patients undergoing elective surgical procedures under general anesthesia requiring endotracheal intubation at Kasr Al-Ainy Hospitals.

III. Study Procedures:

  1. Preoperative Assessment: All eligible patients underwent a standardized pre-anesthetic evaluation performed by an anesthesiologist or a trained anesthesia resident, including:
  • Detailed medical and surgical history
  • Physical examination
  • Routine laboratory investigations Anthropometric Measurements and WWI Calculation Waist circumference (WC) was measured in centimeters while patients were wearing disposable non-woven clothing and no footwear, at the midpoint between the iliac crest and the lowest rib. Body weight was measured using a calibrated digital scale. WWI Calculation:
  • WWI was calculated using the formula:
  • WWI=Waist Circumference (cm) ÷ √Weight (kg)
  • Higher WWI values indicate greater central adiposity. Airway Assessment Preoperative airway evaluation included:
  • Modified Mallampati classification
  • Thyromental distance
  • Mouth opening (inter-incisor distance)
  • Neck movement
  • Prognathism
  • Neck circumference (measured at the level of the thyroid cartilage)
  • El-Ganzouri Risk Index (EGRI) The El-Ganzouri Risk Index was calculated using its standard components: Mouth opening, Thyromental distance, Mallampati score,Neck movement,Prognathism,Body weight
  • History of difficult intubation The score was calculated using MedCalc software.
  1. Intraoperative Management:

Patient Positioning and Monitoring Upon arrival to the operating theatre, patients were positioned in the dorsal decubitus position. The head was supported with a pillow to achieve the sniffing position, aligning the external auditory meatus with the sternal notch.

Standard monitoring was applied, including:

  • Electrocardiography (ECG)
  • Non-invasive blood pressure
  • Pulse oximetry
  • Capnography
  • Temperature monitoring Premedication After intravenous cannulation, all patients received midazolam 2 mg IV as premedication.

Preoxygenation Preoxygenation was performed using a tight-fitting face mask for 3 minutes to ensure adequate oxygen reserves before anesthesia induction.

Induction of General Anesthesia

  • General anesthesia was induced using:
  • Propofol (1.5-2.5 mg/kg)
  • Fentanyl (1 μg/kg)
  • Atracurium (0.5 mg/kg) Mask Ventilation Following induction, bag-mask ventilation (BMV) was initiated using a two-handed double C-E technique. The attending anesthesiologist who performed mask ventilation had more than one year of experience. Ventilation was continued for approximately 3 minutes to allow adequate neuromuscular blockade.

Assessment of BMV

  • Adequacy of ventilation was confirmed by:
  • Visible chest and abdominal rise
  • Presence of a well-formed capnography waveform

BMV was graded using a 4-point scale:

  1. Ventilated without an oral airway
  2. Ventilated with oral airway/adjunct
  3. Difficult Ventilation:characterized as unstable,inadequate,or requiring two providers despite oral airway/adjunct.
  4. Impossible ventilation:unable to ventilate despite multiple providers or adjuvants.

Laryngoscopy Direct laryngoscopy was performed with a Macintosh blade (sizes 3-5) by an anesthesiologist with at least 1 year of experience. The laryngeal view was classified according to the Cormack-Lehane grading system.

Endotracheal Intubation Following laryngoscopy, endotracheal intubation was attempted using an appropriately sized tube (7.0-8.0 mm).

The following were recorded:

  • Number of intubation attempts
  • Cormack-Lehane grade
  • Success or failure of intubation Management of Failed Intubation

If the first intubation attempt failed, one or more adjuncts were employed as appropriate, including:

  • Application of the BURP (backward, upward, rightward pressure) maneuver
  • Use of an endotracheal tube stylet/Bougie
  • Change of laryngoscope blade (from Miller to Macintosh or vice versa or McCoy)
  • Substitution of the laryngoscopist with a more experienced anesthesiologist (a senior anesthesia resident, or a consultant anesthesiologist)
  • Use of video laryngoscopy
  • Use of supraglottic airway devices If the second intubation attempt by the consultant anesthesiologist failed, a third attempt was performed by the consultant anesthesiologist after selecting an alternative adjunct from the previously mentioned options.

Failed intubation was defined as the inability to achieve successful tracheal intubation after three attempts by an experienced anesthesiologist.

Maintenance of Anesthesia and Ventilation

After successful intubation:

  • Anesthesia was maintained using sevoflurane (2%) in 50% oxygen
  • Mechanical ventilation was initiated using volume-controlled mode
  • Ventilation was adjusted to maintain end-tidal CO₂ between 32-34 mmHg Definition of Difficult Airway

A difficult airway was defined as any of the following:

  • BMV grade ≥3
  • Cormack-Lehane grade ≥3
  • ≥3 intubation attempts Reversal and Emergence

At the end of surgery:

  • Anesthesia was discontinued
  • Neuromuscular blockade was reversed using:
  • Neostigmine (0.05 mg/kg)
  • Atropine (0.02 mg/kg) IV. Data Collection and Measurements The following variables were recorded: Demographics and Patient Characteristics Age (years) Sex Weight (Kg) Height BMI ASA score Type of surgery Anthropometric Waist circumference WWI Neck circumference (cm) Airway Variables Mallampati score Sternomental distance (cm) EGRI score BMV grade Cormack-Lehane grade Intubation Data Number of attempts Use of adjuncts V. Study Outcomes
  1. Primary outcome:
  • The correlation coefficient between WWI and the incidence of difficult intubation.
  1. Secondary outcome(s)
  • Incidence of difficult intubation.Difficult intubation was defined as requiring two or more attempts, as this threshold allows earlier detection of clinically relevant airway difficulty and has been adopted in recent airway research.
  • Predictive accuracy of WWI to predict (ROC curve, sensitivity, specificity, AUC).
  • The cutoff value of WWI to predict difficult intubation.
  • Comparing the predictive ability of WWI to BMI to predict difficult airway
  • Correlation between WWI and: Difficult mask ventilation , El-Ganzouri score , Neck circumference, sternomental distance, Mallampati score VI. Sample Size Calculation The sample size was calculated using MedCalc software (version 20), based on an expected correlation coefficient (r = 0.41) derived from a pilot study conducted on 5 patients. With a power of 80% and a significance level of 5%, the required sample size was determined. To account for potential dropout, 6 additional patients were included, resulting in a total sample size of 50 patients.
Being tested
Weight, Height, BMI, Waist circumference, WWI, Neck circumference, Mallampati score, Sternomental distance, EGRI score, BMV grade Cormack-Lehane grade,Number of attempts Use of adjunts
Keywords
Weight-Adjusted Waist Index, Obesity, Difficult intubation, General anesthesia
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight, Height, BMI, Waist circumference, WWI, Neck circumference, Mallampati score, Sternomental distance, EGRI score, BMV grade Cormack-Lehane grade,Number of attempts Use of adjuntsOther

    Anthropometric Measurements and WWI Calculation:

    Waist circumference (WC) was measured while patients were wearing disposable non-woven clothing and no footwear, at the midpoint between the iliac crest and the lowest rib.

    Body weight was measured using a calibrated digital scale.

    WWI Calculation:

    • WWI was calculated using the formula:
    • WWI=Waist Circumference (cm) ÷ √Weight (kg)
    • Higher WWI values indicate greater central adiposity

    Preoperative airway evaluation included:

    • Modified Mallampati classification
    • Thyromental distance
    • Mouth opening (inter-incisor distance)
    • Neck movement
    • Prognathism
    • Neck circumference (measured at the level of the thyroid cartilage)
    • El-Ganzouri Risk Index (EGRI) The El-Ganzouri Risk Index was calculated using its standard components: Mouth opening, Thyromental distance, Mallampati score,Neck movement,Prognathism,Body weight
    • History of difficult intubation The score was calculated using MedCalc software.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The correlation between weight-adjusted waist index (WWI) and the incidence of difficult intubation.

    WWI measured preoperatively by a digital scale. Difficult intubation will be assessed by airway examination

    Measured: from preoperative assessment until intubation up to 5 minutes after intubation

Secondary outcomes (9)
  1. Incidence of difficult intubation

    Difficult intubation was defined as requiring two or more attempts, as this threshold allows earlier detection of clinically relevant airway difficulty and has been adopted in recent airway research.

    Measured: from intubation attempt until intubation success up to 5 minutes after intubation

  2. Predictive accuracy of WWI to predict difficult intubation

    Measured: from preoperative assessment until intubation success up to 5 minutes after intubation

  3. The cutoff value of WWI to predict difficult intubation.

    Measured: from preoperative assessment until intubation success up to 5 minutes after intubation

  4. Comparing the predictive ability of WWI to BMI to predict difficult airway

    Measured: from preoperative assessment until intubation success up to 5 minutes after intubation

  5. Correlation between weight-adjusted waist index (WWI) and Difficult mask ventilation

    WWI measured preoperatively by a digital scale. Difficult ventilation will be assessed by examination. Correlation will be evaluated using the Pearson's or Spearman's correlation coefficient.

    Measured: from preoperative assessment until intubation success up to 5 minutes after intubation

  6. Correlation between weight-adjusted waist index (WWI) and El-Ganzouri score

    WWI measured preoperatively by a digital scale. El-Ganzouri will be assessed by airway examination. Correlation will be evaluated using the Pearson's or Spearman's correlation coefficient.

    Measured: from preoperative assessment until successful intubation up to 5 minutes after intubation

  7. Correlation between WWI and Neck circumference

    WWI measured preoperatively by a digital scale. Neck circumference will be assessed by a tape. Correlation will be evaluated using the Pearson's or Spearman's correlation coefficient.

    Measured: from preoperative assessment until successful intubation up to 5 minutes after intubation

  8. Correlation between weight-adjusted waist index (WWI) and sternomental distance

    WWI will be measured preoperatively by a digital scale. Sternomental distance will be measured by a ruler. Correlation will be evaluated using the Pearson's or Spearman's correlation coefficient.

    Measured: from preoperative assessment until successful intubation up to 5 minutes after intubation

  9. Correlation between WWI and Mallampati score

    WWI will be measured preoperatively by a digital scale. The Mallampati score will be assessed by airway examination. Correlation will be evaluated using the Pearson's or Spearman's correlation coefficient.

    Measured: from preoperative assessment until successful intubation up to 5 minutes after intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start1 Nov 2025
  3. Primary completion25 Mar 2026
  4. Study completion25 Mar 2026

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07894692
Sponsor's protocol ID
MS-448-2025
Acronym
WWI
Status last verified
Sep 2025
First submitted
15 Jun 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No: for patient privacy

Questions about this trial

What is this clinical trial studying?

An observational study of General Anesthesia; Tracheal Intubation, run by Cairo University at 1 site in Egypt.

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 1 inclusion and 12 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 26 Oct 2026. 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 Egypt. 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?

The correlation between weight-adjusted waist index (WWI) and the incidence of difficult intubation. (time frame: from preoperative assessment until intubation up to 5 minutes after intubation). 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 26 Oct 2026.

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