A study to assess the effect of thermal softening of endotracheal tube in reducing post operative sore throat
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2022/03/040813
- Lead Sponsor
- RajaRajeswari Medical College and Hospital
- Brief Summary
**Introduction**
Sore throat is one of the common postoperative complications.
Incidence of post-operative sore throat (POST) varies from 14.4% to 50% [1–8]. It leads to dissatisfaction and discomfort after surgery and can delay a patient’s return to normal routine activities [9]. POST has been rated by patients as the eighth most adverse effect in the postoperative period [10].
Non-pharmacological and pharmacological methods have been used for attenuating POST.
Among non-pharmacological methods, small sized endotracheal tubes (ETTs), [11] smooth laryngoscopy and intubation, minimizing cuff pressure,[12] lubricating the tubes with water soluble jelly,[13] gentle oropharyngeal suctioning and extubation when the cuff is fully deflated have been reported to decrease the incidence of POST.
However, various pharmacological agents such as steroids (dexamethasone, betamethasone, fluticasone, methylprednisolone),[14,15,16,17] opioids,[18] local anaesthetic agents,[19] nonsteroidal anti-inflammatory drugs (NSAIDs),[20] α agonists,[21] and ketamine[22] were used with the aim of reducing the occurrence of POST after GA.
Thermal softening of the ETT can reduce the stiffness and increase flexibility of the tube, and has thus been used to reduce nasal damage during naso-tracheal intubation(23,24). It was recently found to be effective in decreasing the incidence of postoperative sore throat and vocal cord injuries during double-lumen endotracheal intubation.(25)
There were no previous studies with regard to thermal softening of endotracheal tube for orotracheal intubation. Therefore, we hypothesized that the thermal softening of ETT may decrease sore throat associated with orotracheal intubation.
**Aims and objectives of the study:**
Primary objective is to evaluate the effect of thermal softening of endotracheal tube for post operative sore throat.
Secondary objectives
· To evaluate for cough and hoarseness of voice in post operative period
· side effects (if any).
Materials and methods
Source of data will be patients undergoing surgeries under General anaesthesia done in Rajarajeswari Medical College and Hospital. A hospital based prospective, double blinded randomized control clinical study will be conducted from March 2022 to February 2023.
Inclusion criteria for our study will be Patients who give written informed consent ,aged 18-60 yrs, who are scheduled for elective surgery under General anesthesia (<2hrs)with ASA (American society of anesthesiologists) grade I & II.
• Exclusion criteria includes Patients refusing to participate in the study ,ongoing acute infections,preoperative sore throat ,electrolyte abnormalities, hepatic and renal dysfunction, chronic alcohol abuse ,long term analgesic therapy, history of endocrine disease inclusive of diabetes mellitus, Morbid obesity, chronic use of steroids or immunosuppressant or recent chemotherapy, difficult airway and pregnant and lactating patients.
**Methodology**
• Informed written consent, participation consent and surgeon consent and approval from Institutional Ethical Committee will be obtained, patients will be randomly allocated to one of the two groups using numbers generated from www.random.org. A proforma will be used to collect the data which includes patient’s particulars, indication for surgery, ASA of the patient, hemodynamics during the procedure and post operative sore throat.
• 270 Patients of either sex will be randomly allocated to 2 different groups of 135 patients each as described below
• Group C – Control group. Endotracheal tube will be immersed in normal saline which is at room temperature for 10 minutes.
• Group T – thermal softening of ET group. Endotracheal tube will be immersed in normal saline which is at 40 0C for 10 min.
• Preparation of the endotracheal tube: endotracheal tube cuffs will be deflated and distal portion of the tube will be immersed in a sterile normal saline for 10 minutes prior to intubation. The temperature of the normal saline will be maintained at operating room temperature for control group and at 400 C for thermal softening group. Mercury thermometer will be used to measure the saline temperature. To maintain the temperature of the saline foil will be used to wrap.
• All patients will be kept fasting overnight ,patients will be given Tablet Alprazolam 0.5mg and Tablet Rantidine 150 mg on the previous night of surgery.
• Anaesthetic procedure :
• Monitoring will include electrocardiography (ECG), oxygen saturation (SpO2), non-invasive blood pressure(NIBP), respiratory rate (RR),end tidal carbon di oxide (EtCO2) , train of four (TOF).
• Patients will be informed regarding the anaesthetic procedure.
• Intravenous (IV) access will be established and an IV infusion of Ringer lactate will be started.
• In all the groups general anaesthesia will be given to the patients, patients will be premedicated with Inj Glycopyrrolate 10µg/Kg IV, Inj Midazolam 0.03mg/Kg and Inj Fentanyl 2µ/Kg and patient will be preoxygenated.
• Patients will be induced with Inj Propofol (2mg/Kg) followed by Inj Vecuronium 0.1mg/kg. After 3 minutes, laryngoscopy done Cormack Lehane grading assessed before intubation and intubation will be done with appropriate sized cuffed endotracheal tube.
• Anaesthesia will be maintained with Oxygen 33%. Nitrous Oxide 66% and Isoflurane 1-2%, injection vecuronium for maintenance of muscle paralysis.
• At the end of surgery patient will be reversed with Glycopyrrolate 10mcg/kg and Neostigmine 0.05mg/kg IV and will be extubated when TOF ratio >0.8.
• Cuff pressure will be monitored and kept below 25mmH2O
• Parameters measured :
• Basic Parameters such as Heart rate (HR) ,Systolic Blood Pressure(SBP),Diastolic Blood Pressure(DBP),Mean Arterial Pressure(MAP),Saturation of oxygen(spO2),End tidal carbon dioxide (EtCO2) will be monitored during the entire surgery.
• Post operative: parameters will be assessed one hour ,six hours and 24 hours(15) after the surgery by anaesthesiologist who is not involved in the study.
• **Sore throat**
| | |
| --- | --- |
|**Score 0**
**No sore throat at any time since the operation**
|**1**
The patient answers in the affirmative when asked about sore throat (minimal sore throat)
|**2**
Patient complained of sore throat on his/her own (moderate sore throat)
|**3**
Patient is in obvious distress (severe sore throat)
• Cough
| | |
| --- | --- |
|**Score 0**
**No cough at any time since the operation**
|**1**
Minimal cough (scratchy throat)
|**2**
Moderate cough
|**3**
Severe cough
• Hoarseness
| | |
| --- | --- |
|**Score 0**
**No complaint of hoarseness at any time since the operation**
|**1**
Minimal change in quality of speech.patient answers in affirmative only when enquired
|**2**
Moderate change in quality of speech of which patient complains on his /her own
|**3**
Gross change in quality of voice perceived by the observer
**Statistical analysis**
• Data will be entered into Microsoft excel data sheet and will be analyzed using SPSS 22 version software. Categorical data will be represented in the form of Frequencies and proportions. Chi-square will be the test of significance. Continuous data will be represented as mean and standard deviation. ANOVA test will be the test of significance to identify the mean difference between the groups. p value <0.05 will be considered as statistically significant.
Incidence of POST in thermal softening group was 35.1% and in control group was 52.7%. Using these values 135 samples was obtained per group. Hence 135+135 = 270 subjects based on **Je Hyuk Yu** et al study. (26)
List of references
1. Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. British Journal of Anaesthesia 1994; 73: 786–7.
2. Harding CJ, McVey FK. Interview method affects incidence of postoperative sore throat. Anaesthesia 1987;42: 1104–7.
3. Herlevsen P, Bredahl C, Hindsholm K, Kruhoffer PK.Prophylactic laryngo-tracheal aerosolized lidocaine against postoperative sore throat. Acta Anaesthesiologica Scandinavica 1992; 36: 505–7.
4. Jorgensen LN, Weber M, Pedersen A, Munster M. No increased incidence of postoperative sore throat after administration of suxamethonium in endotracheal anaesthesia. Acta Anaesthesiologica Scandinavica 1987; 31:768–70.
5. Joshi GP, Inagaki Y, White PF, et al. Use of the laryngeal mask airway as an alternative to the tracheal tube during ambulatory anesthesia. Anesthesia and Analgesia 1997; 85:573–7.
6. Stout DM, Bishop MJ, Dwersteg JF, Cullen BF. Correlation of endotracheal tube size with sore throat and hoarseness following general anaesthesia. Anesthesiology 1987; 67: 419–21.
7. Stride PC. Postoperative sore throat: topical hydrocortisone. Anaesthesia 1990; 45: 968–71.
8. Winkel E, Knudsen J. Effects on the incidence of postoperative sore throat of 1 percent cinchocaine jelly for endotracheal intubation. Anesthesia and Analgesia 1971; 50:92–4.
9. Lehmann M, et al. Postoperative patient complaints: a prospective interview study of 12,276 patients. J Clin Anesth. 2010;22(1):13–21.
10. Macario A, et al. Which clinical anesthesia outcomes are important to avoid?The perspective of patients. Anesth Analg. 1999;89(3):652–8.
11. Al-Qahtani AS, Messahel FM. Quality improvement in anesthetic practice – Incidence of sore throat after using small tracheal tube. Middle East J Anaesthesiol. 2005;18:179–83.[PubMed: 15830773]
12. Suzuki N, Kooguchi K, Mizobe T, Hirose M, Takano Y, Tanaka Y. Postoperative hoarseness and sore throat after tracheal intubation: Effect of a low intracuff pressure of endotracheal tube and the usefulness of cuff pressure indicator. Masui. 1999;48:1091–5.[PubMed: 10554500]
13. Estebe JP, Delahaye S, Le Corre P, Dollo G, Le Naoures A, Chevanne F, et al.Alkalinization of intra-cuff lidocaine and use of gel lubrication protect against tracheal tube-induced emergence phenomena. Br J Anaesth. 2004;92:361–6. [PubMed: 14970135]
14. Jung H, Kim HJ. Dexamethasone contributes to the patient management after ambulatory laryngeal microsurgery by reducing sore throat. Eur Arch Otorhinolaryngol.2013;270:3115–9. [PubMed: 24057101]
15. Sumathi PA, Shenoy T, Ambareesha M, Krishna HM. Controlled comparison between betamethasone gel and lidocaine jelly applied over tracheal tube to reduce postoperative sore throat, cough, and hoarseness of voice. Br J Anaesth. 2008;100:215–8. [PubMed:18024955]
16. Tazeh-Kand NF, Eslami B, Mohammadian K. Inhaled fluticasone propionate reduces postoperative sore throat, cough, and hoarseness. Anesth Analg. 2010;111:895–8. [PubMed:20237046]
17. Lévy B, Mouillac F, Quilichini D, Schmitz J, Gaudart J, Gouin F. Topical methylprednisolone vs lidocaïne for the prevention of postoperative sore throat. Ann Fr Anesth Reanim. 2003;22:595–9. [PubMed: 12946491]
18. Jiao L, Liu RC. Effects of dezocine on postoperative sore throat after maxillofacial procedures: A comparison with flurbiprofen axetil. Beijing Da Xue Xue Bao. 2014;46:104–6.[PubMed: 24535359]
19. Hung NK, Wu CT, Chan SM, Lu CH, Huang YS, Yeh CC, et al. Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg. 2010;111:882–6. [PubMed: 20304980]
20. Agarwal A, Nath SS, Goswami D, Gupta D, Dhiraaj S, Singh PK. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: A prospective, randomized, single-blind study. Anesth Analg. 2006;103:1001–3.[PubMed: 17000820]
21. Maruyama K, Yamada T, Hara K. Effect of clonidine premedication on postoperative sore throat and hoarseness after total intravenous anesthesia. J Anesth. 2006;20:327–30.[PubMed: 17072702]
22. Ahuja V, Mitra S, Sarna R. Nebulized ketamine decreases incidence and severity of post-operative sore throat. Indian J Anaesth. 2015;59:37–42. [PMCID: PMC4322100][PubMed: 25684812]
23. Hosseinzadeh H, Taheri Talesh K, Golzari SE, Gholizadeh H, Lotfi A, Hosseinzadeh P. Warming endotracheal tube in blind nasotracheal intubation throughout maxillofacial surgeries. J Cardiovasc Thorac Res. 2013;5:147-151.
24. Seo KS, Kim JH, Yang SM, Kim HJ, Bahk JH, Yum KW. A new technique to reduce epistaxis and enhance navigability during nasotracheal intubation. Anesth Analg. 2007;105:1420-1424.
25. Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016;116:282-288.
26. Yu JH, Paik HS, Ryu HG, Lee H. Effects of thermal softening of endotracheal tubes on postoperative sore throat: A randomized double-blinded trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):213-219. doi: 10.1111/aas.13705. Epub 2020 Sep 23. PMID: 32926423.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 270
- Patients who give written informed consent.
- Patients aged 18-60 yrs.
- Patients scheduled for elective surgery under General anesthesia (<2hrs) Patients with ASA (American society of anesthesiologists) grade I & II.
- Patients refusing to participate in the study.
- Patients having ongoing acute infections.
- Patients with preoperative sore throat Patients with electrolyte abnormalities.
- Patients with hepatic and renal dysfunction.
- Patients with chronic alcohol abuse.
- Patients on long term analgesic therapy.
- Patients with history of endocrine disease inclusive of diabetes mellitus.
- Morbid obesity, chronic use of steroids or immunosuppressant or recent chemotherapy.
- Patients with difficult airway.
- Pregnant and lactating patents.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of thermal softening of endotracheal tube in reducing post operative sore throat. Sore throat will be evaluated for one hour, six hours and twenty four hours in the post operative period | Â Â Sore throat will be evaluated for one hour, six hours and twenty four hours in the post operative period | Â
- Secondary Outcome Measures
Name Time Method To evaluate for cough and hoarseness of voice in post operative period. side effects(if any)
Trial Locations
- Locations (1)
RajaRajeswari Medical College and Hospital
🇮🇳Bangalore, KARNATAKA, India
RajaRajeswari Medical College and Hospital🇮🇳Bangalore, KARNATAKA, IndiaChaithali HebriPrincipal investigator9972674755chaithali.acharya@gmail.com