Health Condition 1: 2- Placement
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged 18 to 65 years. ASA physical status classification I-III. Patients with predicted difficult airway based on guidelines including (American Society of Anesthesiologists Difficult Airway Algorithm): Mallampati class III or IV. Interincisor gap less than 4 cm. Thyromental distance less than 6 cm. Sternomental distance less than 12 cm. Neck circumference greater than 40 cm. Limited neck mobility or reduced mandibular protrusion. History of difficult intubation. Oral or laryngeal pathology compromising airway anatomy (e.g., tumors, infections, scarring). Patients must be scheduled for elective surgery requiring general anesthesia and tracheal intubation.
Exclusion criteria
Exclusion criteria: ASA physical status IV or above Age under 18 or over 65 years Emergency and urgent surgeries Patients refusing consent or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First-attempt intubation success rate using video laryngoscopy with either the steerable bougie or the CMAC stylet.Timepoint: At the time of the intubation attempt (intraoperative). | — |
Secondary
| Measure | Time frame |
|---|---|
| Total number of intubation attempts required for successful tube placement.Timepoint: Total number of intubation attempts required for successful endotracheal tube placement, assessed at the time of confirmation of tracheal intubation by continuous waveform capnography.;Time taken from insertion of the laryngoscope to confirmation of endotracheal tube placement.Timepoint: Time to intubation was defined as the interval from insertion of the laryngoscope blade into the oral cavity to confirmation of endotracheal tube placement by continuous waveform capnography.;Operator-rated ease of use of the intubation deviceTimepoint: Operator-rated ease of use of the intubation device, assessed immediately after completion of the intubation procedure.;Requirement for laryngeal manipulation during intubationTimepoint: Requirement for external laryngeal manipulation during intubation, assessed during the intubation attempt.;Incidence of complications, including hypoxia, esophageal intubation, dental trauma, and hemodynamic instabilityTimepoint: Incidence of complications, including hypoxia, esophageal intubation, dental trauma, and hemodynamic instability, assessed during the intubation procedure and in the immediate post-intubation period. | — |
Countries
India
Contacts
Christian Medical College, Vellore