Comparison of two airway securing devices in patients undergoing Cerebrospinal Fluid Diversion Surgery.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/10/046878
• Lead Sponsor: Post Graduate Institute of Medical Education and Research Chandigarh

Brief Summary

After clearance from the institutional ethical committee (IEC), registering in CTRI, and obtaining written informed consent, 50 patients will be randomized into two study groups based on a computer-generated random number. The group allocation will be concealed by keeping the numbers in sealed opaque envelopes that will be opened just prior to shifting the patient to the operation room (OR).

The patient will be shifted into the OR and standard American Society of Anesthesiologists (ASA) monitoring like electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SPO2), and temperature will be initiated. An intravenous (IV) line will be secured and 0.9% normal saline will be infused. General anaesthesia induction will be done with an IV injection of fentanyl 2mcg/ kg and injectionpropofoL 1-2.5 mg/kg in titration till loss of verbal response. After establishing bag and mask ventilation, IVinjectionvecuronium 0.1 mg/kg will be used for muscle relaxation under the guidance of neuromuscular transmission (NMT) monitoring. Preoxygenation will be carried out for four minutes. Following the airway will be secured with either PLMA or ETI as per group allocation.

**Group P:** PLMA (size 3 for 30–50 kg, size 4 for 50–70 kg, and size 5 for >70 kg patients) will be used to secure the airway.

**Group E:** ETT (size 8.0/8.5 mm for males and size 7.0/7.5 mm for females) of appropriate size will be used to secure the airway.

Proper placement of the PLMA and ETT will be confirmed by capnography, bilateral symmetrical chest rises, and air entry on chest auscultation. No audible leaking sound, good thoracic undulation, stable pulse oxygen saturation (>95%), and capnography will be considered successful ventilation. Air leaks will be verified by auscultation at the different head positions (neutral, anterior flexion, and left and right rotation) to determine whether ventilation of PLMA is successful. If PLMA fails (more than 3 attempts) to achieve successful ventilation, then the airway will be secured with ETI. Patients in both groups will be ventilated using volume control mode and tidal volume (VT) and respiratory rate (RR) will be adjusted to maintain end-tidal carbon dioxide between 30-35 mm Hg. Maintenance of anaesthesia will be done with 50:50% oxygen:nitrous oxide with sevoflurane, intermittent vecuronium [as per train of four (TOF) count], and fentanyl as per patient requirement. In both groups, ONSDs will be measured in both eyes using an ultrasonography device in the supine position. A Tegaderm will be used to cover the closed eye so that the water-soluble gel doesn’t enter the eye. A 7.5 MHz linear ultrasound probe will be gently placed in a transverse plane over the gel. The ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The ONSD measurement values will be determined for each eye by calculating the mean value of the 3 measurements. It will be measured before intubation (T0), immediately after intubation (T1), after 5 minutes (T2), and after 10 minutes (T3). The patient will be handed over to the surgeon to carry out the surgery. Following completion of the surgery, with the onset of spontaneous respiration and a TOF count of 4, the patient will be reversed with IVinjectionglycopyrrolate 10 mcg/kg and injection of neostigmine 50 mcg/kg. PLMA or ETT will be removed, once the patients become conscious and follow the command.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-11
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients aged 18 to 65 years, either gender 2.
• ASA I and II 3.
• Scheduled for VP shunt surgery under general anaesthesia will be included in the study.

Exclusion Criteria

• Patients refusal to participate in the study.
• Features of acute raised intracranial pressure (bradycardia with hypertension, deranged neurological status, and active nausea and vomiting) 3.
• Patient with an anticipated difficult airway 4.
• ASA Physical Status III or IV 5.
• Body mass index >30 kgm−2 6.
• Upper respiratory tract infection 7.
• Increased risk of aspiration (unknown nil per os status, gastroesophageal reflux disorder, hiatus hernia, pregnancy, and diabetic patients) 8.
• Cervical spine fracture or instability.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the change in ONSD	5 minutes from baseline after securing the airway between both groups

Secondary Outcome Measures

Name	Time	Method
• Comparison of the hemodynamic parameters (Heart rate, Mean arterial pressure, oxygen saturation)	• Ventilation parameters like tidal volume (VT), respiratory rate (RR), and peak airway pressure.

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research (PGIMER); 🇮🇳 Chandigarh, CHANDIGARH, India

Post Graduate Institute of Medical Education and Research (PGIMER)

🇮🇳Chandigarh, CHANDIGARH, India

Amiya Kumar Barik

Principal investigator

08052919523

amiyabarik.scb@gmail.com