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CompletedNCT07894692WWIUpdated Oct 26, 2026

Association of WWI With Difficult Intubation

An observational study in General Anesthesia; Tracheal Intubation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Cairo University · Observational

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

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.

I. 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.
  2. 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.

    2. 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.
02

Conditions studied

  • General Anesthesia; Tracheal Intubation

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Keywords

  • Weight-Adjusted Waist Index
  • Obesity
  • Difficult intubation
  • General anesthesia
03

In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 50 is below the median of 132 across 1,338 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients scheduled for any surgical procedures who need endotracheal intubation to conduct GA.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
    • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

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

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: from preoperative assessment until intubation up to 5 minutes after intubation

Secondary outcomes

  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.

    Time frame: from intubation attempt until intubation success up to 5 minutes after intubation

  2. Predictive accuracy of WWI to predict difficult intubation

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

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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

Other outcomes

  1. Demographics and Patient Characteristics

    Time frame: from preoperative assessment until intubation up to 5 minutes after intubation

  2. number of intubation attempts

    Time frame: from intubation attempt until intubation success up to 5 minutes after intubation

  3. number of airway adjuncts used for intubation

    Time frame: from the beginning of intubation until successful intubation up to 5 minutes after intubation

07

Study locations

1 site
  • Kasr Alainy Hospital
    Cairo, Almanial 12211, Egypt
08

References and documents

Individual participant data

Plan to share: No — for patient privacy

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07894692
Lead sponsor
Cairo University
Responsible party
Hany Mohammed El-Hadi Shoukat Mohammed (Assistant professor, Cairo University) — Principal investigator
First posted
Oct 26, 2026
Start date
Nov 1, 2025
Primary completion
Mar 25, 2026
Completion
Mar 25, 2026
Last update
Oct 26, 2026

Oversight

Data monitoring committee
No
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