Comparing the effectiveness of two ways of mask ventilation in obese adult patients

Not yet recruiting

• Conditions: Patients posted for elective surgeries under general anaesthesia

• Registration Number: CTRI/2019/06/019934
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

Bag mask ventilation is required in nearly all general anaesthesia patients for a certain time after induction is achieved. This basic airway management technique permits oxygenation and ventilation of a patient until a more definitive airway can be established.The principal challenge in performing a bag mask ventilation is forming an effective seal over the patient’s face. Obese patients are often difficult to mask ventilate and are also a group of patients with lower oxygen reserves and a higher rate of oxygen consumption in whom inadequate bag mask ventilation may lead to rapid oxygen desaturation. The conventional teaching of bag mask ventilation uses C-E technique which is also more popular but it is unknown whether both techniques( C-E and V-E) are attempted in practice, or if one is preferred over the other. There is a paucity of studies comparing the two handed C-E technique and V-E technique of mask holding for their effectiveness in facilitating face  mask ventilation.

Patients aged 18-60 years requiring general aneasthesia fulfilling inclusion/ exclusion criteria will be recruited. The subjects will be placed on the operating room table in 15 degree head up ramped position. Appropriate size pillow will be used to align the external auditory meatus and sternal notch. All standard monitors will be attached and baseline values recorded. Preoxygenation will be carried out using face mask with a flow rate of 10 liter/min of 100% oxygen until expired oxygen concentration reached ~ 80%. An intravenous bolus of injection fentanyl 2 microgram/kg according to ideal body weight (IBW) will be given before induction. Induction of anaesthesia will be achieved by an intravenous bolus injection of propofol 2-2.5 mg/kg according to IBW. After checking for ventilation IV injection vecuronium 0.1 mg/kg of IBW will be given. One minute of stabilization will be given. After apnea, depending on the group allocated, the patients will be ventilated with first mask technique. Ventilation will be obtained with the ventilator set to pressure control mode at a rate of 10 bpm, inspiratory to expiratory time ratio (I:E) 1:2, peak inspiratory pressure of 15 cm of water and no PEEP. After stabilization period of 1 minute, 10 consecutive breaths data over next one minute will be recorded. Thereafter, mask ventilation will be carried out using  the second technique. one minute of stabilization time will be given and next 10 consecutive breaths will be recorded. If the mask ventilation fails with consecutive breaths, the mask ventilation technique will be changed to the other technique. If at any time, the SPO2 is less than 94% during a mask ventilation attempt, the technique will be considered as failure and it will be changed to other technique.

After the study protocol is over,the airway and anaesthesia will be managed as per the requirement of the case. Expired tidal volume and end tidal carbon dioxide for each breath will be recorded. Statistical analysis will be done using Wilcoxon signed rank test or student paired t test.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Patients of American Society of Anaethesiologists physical status I/II with BMI more than or equal to 30 kilogram per squared metre.

Exclusion Criteria

Acute and chronic respiratory disorders Patients requiring rapid sequence intubation Patients requiring awake intubation Patients with dressing or scars or raw area over face Intra oral or pharyngeal swellings or masses Edentulous patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean expired tidal volume	intraoperatively

Secondary Outcome Measures

Name	Time	Method
Mean expired tidal volume/actual weight	intraoperatively
Mean expired tidal volume/predicted body weight	intraoperatively

Trial Locations

Locations (1)

Lok Nayak Hospital; 🇮🇳 Delhi, DELHI, India

Lok Nayak Hospital

🇮🇳Delhi, DELHI, India

Dr Ghazala Anis Fatima

Principal investigator

8826088453

ghazalafatima08@gmail.com