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A randomised study of Comparison of ease of insertion and nasal bleeding with Ivory Polyvinylchloride north pole tube versus reinforced Armored tube in patients undergoing head and neck surgery under general anesthesia with video-laryngoscope guided insertion of tube through nose in airway pipe.

Comparison of ease of intubation and epistaxis with Ivory Polyvinylchloride north pole versus Armored tube in patients undergoing head and neck surgery under general anesthesia with video-laryngoscope guided nasotracheal intubation: A randomized parallel arm study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077357
Enrollment
100
Registered
2024-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue

Interventions

Intervention1: Ivory polyvinylchloride north pole tube: Ivory PVC North pole tube will be inserted after induction of general anesthesia using video laryngoscopy guided nasotracheal intubation in pati

Sponsors

All India Institute of Medical Sciences Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II undergoing elective head and neck surgeries with nasotracheal intubation under general anaesthesia

Exclusion criteria

Exclusion criteria: 1.Anticipated difficult laryngoscopy with Mallampati Classification III or IV, mouth opening less than 3 cm, Thyromental distance less than 6cm, limited neck extension, history of history of documented difficult tracheal intubation. 2.Poor cardiorespiratory reserve- Serious respiratory disease, Arrythmias or preexisting hemodynamic instability, LVEF less than 35%. 3.Contraindication to nasotracheal intubation -Bilateral nasal polyp, Adenoids, chronic suppurative Sinusitis, cervical spine instability, coagulopathy Low platelet count less than 1 lakhs/cumm, INR more than 1.4, on ongoing anticoagulant therapy. 4. Vulnerable patients- Pregnancy, psychiatric illness, pediatric age group. 5.We will also exclude patients where the experienced anesthesiologist is unable to insert endotracheal tube nasally or insert video-laryngoscope in oral cavity due to unanticipated causes or is unable to obtain any glottic view.

Design outcomes

Primary

MeasureTime frame
1)Frequency of epistaxis in nasotracheal intubation with ivory polyvinyl chloride North Polar tube versus armored endotracheal tube with Video laryngoscope guided nasotracheal intubation in patients undergoing head and neck surgery. 2)Frequency of patients with easy, minor difficult and difficult intubation difficult score in nasotracheal intubation with Ivory polyvinyl chloride North Polar tube versus armored endotracheal tube with Video laryngoscope guided nasotracheal intubation in patients undergoing head and neck surgeryTimepoint: 1) 5 minutes after intubation. 2) During Induction

Secondary

MeasureTime frame
1 Time needed in seconds (total and phase wise)for nasotracheal intubation in Ivory polyvinyl chloride North Polar tube versus armored endotracheal tube with Video laryngoscope guided nasotracheal intubation in patients undergoing head and neck surgery.Timepoint: During induction;To compare hemodynamic response and complications in Ivory polyvinyl chloride North Polar tube versus armored endotracheal tube with Video-laryngoscope guided nasotracheal intubation in patients undergoing head and neck surgery.Timepoint: At start of preoxygenation,laryngoscopy,and 1,3,5 and 10 minutes after intubation.;To compare complications of tube related complications (cuff tear, blockage), injury(dental, nasal, vocal cord) and delayed complications (postoperative sore throat, hoarseness, dysphagia.Timepoint: Post operative at 48 hours after surgery.

Countries

India

Contacts

Public ContactDr Sunaina Tejpal Karna

AIIMS BHOPAL

drtejpal@gmail.com9540946869

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026