Making the endotracheal tube patient friendly

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2020/04/024496

Lead Sponsor: Dr Pinnamaneni Siddhartha Institue of Medical Sciences and Research Foundation

Brief Summary: Smooth emergence has always been the desire of every anaesthesiologist, and also recently, anesthesiologists have been actively participating in the postoperative care, which brings into light the importance of the most common post-extubation complication that is sore throat.

Various methods have been identified to alleviate these complications.

Among all those, one of the simplest measure is cuff pressure maintenance and delivery of a local anesthetic via diffusion during the maintenance period.

This study emphasizes the importance of an initial step (inflation of endotracheal tube cuff) taken while induction and its effect on post-extubation complication and compares various agents with the routinely used agent (air) with an aim to identify the better agent in providing the post-operative care.

The study will be conducted in a double-blinded manner using color-coding given by the statistician for the researcher for different agents, which allows the patient and the researcher to be unaware of the agent used by means of sealed envelopes each containing the consent form, agent, the monitoring chart for data collection.

After taking informed consent the patients are appropriately premedicated, pre oxygenated, induced, and an appropriate muscle relaxant will be given and after intubation with the suitable size polyvinyl chloride cuffed endotracheal tube an agent from one of the groups will be used for inflation of the cuff until ideal cuff pressure is obtained without the cuff leak.

Appropriate amounts of air or normal saline or lignocaine is inflated into the to achieve ideal cuff pressure.

Various objective parameters like hemodynamic parameters including heart rate, respiratory rate, blood pressure, SpO2, ETCO2and cuff pressure and the volume of the agent added or removed for maintenance of the ideal cuff pressure are recorded before the usage of nitrous oxide and every 15 minutes during the entire procedure and another measurement before turning off the nitrous oxide and another final reading of the parameters just before extubation.

Subjective parameters, including sore throat and coughing during extubation, are objectified by using a visual analog scale and binary system (yes/no), respectively.

Presence of sore throat is also assessed on postoperative day one (24 hours assessment)

The data collected will be delivered to the statistician in a master chart prepared according to the alphabet coding not known to the statistician

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

American society of anaesthesiology grade 1 and 2 Mallampati all grades BMI 18.5-24.9.

Exclusion Criteria

Patients with prior respiratory tract infections Patients with prior throat discomfort Patients with prior hoarseness Pregnant women Patients with nasogastric tube More than one attempt intubation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Better tolerable endotracheal intubation with decreased incidence of post operative sore throat and cough	24 hours

Secondary Outcome Measures

Name	Time	Method
not applicable	not applicable

Trial Locations

Locations (1): Department of Anaesthesiology and critical care
🇮🇳
Krishna, ANDHRA PRADESH, India
Department of Anaesthesiology and critical care
🇮🇳Krishna, ANDHRA PRADESH, India
Dr Sudhakar B
Principal investigator
9440174528
sudhakarbillapati@gmail.com