Comparative study on incidence of airway related side-effects while using polyvinyl chloride (PVC) tubes with a strategic cuff release manoeuvre versus armoured flexometallic tubes for artificial ventilation in neurosurgical patients undergoing surgery in side-lying position

Comparative study on incidence of airway related complications while using polyvinyl chloride (PVC) tubes with a strategic cuff release manoeuvre versus armoured flexometallic endotracheal tubes in neurosurgical patients undergoing surgery in lateral position: A non-inferiority trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041527

Enrollment

Registered

2022-03-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: C718- Malignant neoplasm of overlappingsites of brain

Interventions

Intervention1: STRATEGIC CUFF RELEASE IN POLYVINYL CHLORIDE (PVC) TUBES: Cuff of the PVC endotracheal tubes will be deflated during final neck positioning of the patients to aid in free movement of th

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective neurosurgery in lateral position

Exclusion criteria

Exclusion criteria: 1.Patient refusal 2.Difficult airway -mouth opening less than 3 fingers -Modified mallampati grade of III and IV -Receding chin 3.Obesity (BMI >30) 4.History of Bronchial asthma 5.Pregnant women

Design outcomes

Primary

Measure	Time frame
To find the incidence of endotracheal tube kinking intraoperativelyTimepoint: To find the incidence of endotracheal tube kinking intraoperatively	—

Secondary

Measure	Time frame
To assess the incidence of respiratory complications including the incidence and duration of desaturation, number of intubation attempts required and airway injury in immediate postoperative period. Timepoint: Intraoperative period;To assess the incidence of hemodynamic complications including hypotension or hypertension and arrhythmias in immediate postoperative periodTimepoint: In immediate post operative period during tube exchange;To assess the incidence of postoperative airway related complications including sore throat, difficulty in swallowing, difficulty in speech, hoarseness of voice, stridor/laryngeal edema and need for reintubation.Timepoint: From extubation to 48 hours of postoperative period	—

Measure

Time frame

To assess the incidence of respiratory complications including the incidence and duration of desaturation, number of intubation attempts required and airway injury in immediate postoperative period. Timepoint: Intraoperative period;To assess the incidence of hemodynamic complications including hypotension or hypertension and arrhythmias in immediate postoperative periodTimepoint: In immediate post operative period during tube exchange;To assess the incidence of postoperative airway related complications including sore throat, difficulty in swallowing, difficulty in speech, hoarseness of voice, stridor/laryngeal edema and need for reintubation.Timepoint: From extubation to 48 hours of postoperative period

—

Countries

India

Contacts

Public ContactDr Navdeep Sokhal

AIIMS, New Delhi

drnavdeepsokhal@gmail.com9953279619

Outcome results

None listed

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