Assessment of Endotracheal Tube Temperature Effects in Children Undergoing Adenotonsillectomy

NCT06838260 | Completed

• 1 other identifier: Bursa City Hospital 11
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Adenotonsillectomy is one of the most commonly performed surgical procedures in children worldwide. life-threatening complications such as laryngospasm and bronchospasm may develop in the postoperative period. The aim of this study was to compare the effects of using endotracheal intubation tubes at different temperatures during intubation on respiratory complications in the postoperative period in children undergoing adenotonsillectomy.

Conditions

Adenotonsillectomy

Keywords

Adenotonsillectomy in children; Endotracheal tube temperature; Respiratory complications

Outcome Measures

Primary Outcomes (3)

• Rate of laryngospasm

  The rates of laryngospasm occurring in the participants will be determined and compared between the 2 groups

  From extubation until postoperative 2. hour

• Rate of bronchospasm

  The rates of bronchospasm occurring in the participants will be determined and compared between the 2 groups

  From extubation until postoperative 2. hour

• Rate of desaturation

  The rates of desaturation occurring in the participants will be determined and compared between the 2 groups

  From extubation until postoperative 2. hour

Secondary Outcomes (5)

• Heart rate

  7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)

• Mean arterial pressure (MAP) mmHg

  7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)

• Oxygen saturation

  7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care)

• Intraopearative anaesthesia machine respiratory data

  4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery)

• Intraopearative anaesthesia machine respiratory data 2

  4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery)

Study Arms (2)

Group T24 (24°C Endotracheal tube)

ACTIVE COMPARATOR

Anesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation.

Other: 24°C Endotracheal tube

Group T37 (37°C Endotracheal tube)

ACTIVE COMPARATOR

Anesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation.

Other: 37°C Endotracheal tube

Interventions

24°C Endotracheal tube OTHER

A disposable ETT sized appropriately for the age of the patients will be kept in a 40°C incubator (MIR-162) for 30 minutes. An infrared non-contact thermometer will be used to measure the ETT wall temperature. After removal from the incubator, intubation will be performed as soon as the tubes reach a temperature of 24°C for the T1 group by serial measurements. All intubations will be performed by a single anesthesiologist who is not associated with the study.

Group T24 (24°C Endotracheal tube)

37°C Endotracheal tube OTHER

A disposable ETT sized appropriately for the age of the patients will be kept in a 40°C incubator (MIR-162) for 30 minutes. An infrared non-contact thermometer will be used to measure the ETT wall temperature. After removal from the incubator, intubation will be performed as soon as the tubes reach a temperature of 37°C for the T2 group by serial measurements. All intubations will be performed by a single anesthesiologist who is not associated with the study.

Group T37 (37°C Endotracheal tube)

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents who agreed to participate in the study
• Children undergoing adenotonsillectomy
• ASA 1 and 2 class patients

You may not qualify if:

• Emergency surgery
• Children with a history of difficult airway
• Children who have had upper airway surgery
• Presence or suspicion of upper or lower respiratory tract infection
• History of cardiac and respiratory diseases
• Patients with craniofacial malformations

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

Location

Related Publications (6)

• Jeyakumar A, Fettman N, Armbrecht ES, Mitchell R. A systematic review of adenotonsillectomy as a risk factor for childhood obesity. Otolaryngol Head Neck Surg. 2011 Feb;144(2):154-8. doi: 10.1177/0194599810392328.

  PMID: 21634056 BACKGROUND

• Orestes MI, Lander L, Verghese S, Shah RK. Incidence of laryngospasm and bronchospasm in pediatric adenotonsillectomy. Laryngoscope. 2012 Feb;122(2):425-8. doi: 10.1002/lary.22423. Epub 2012 Jan 17.

  PMID: 22252947 BACKGROUND

• Marzban S, Haddadi S, Naghipour MR, Sayah Varg Z, Naderi Nabi B. The effect of intravenous magnesium sulfate on laryngospasm after elective adenotonsillectomy surgery in children. Anesth Pain Med. 2014 Feb 28;4(1):e15960. doi: 10.5812/aapm.15960. eCollection 2014 Feb.

  PMID: 24660159 BACKGROUND

• Mohseni M, Farahmand Rad R, Jafarian AA, Zarisfi AH, Masoudi N. The Effect of Softening of Endotracheal Tubes on the Decrement of Postoperative Hoarseness and Sore Throat. Anesth Pain Med. 2022 Nov 15;12(5):e123910. doi: 10.5812/aapm-123910. eCollection 2022 Oct.

  PMID: 36937172 BACKGROUND

• Yu Y, Jia Q, Zhou L, Liu Z, Liang S, Yang Z, Wan Q. Appropriate tube temperature for fiberoptic bronchoscope-guided intubation of thermally softened double-lumen endotracheal tubes: A CONSORT-compliant article. Medicine (Baltimore). 2022 Oct 7;101(40):e29999. doi: 10.1097/MD.0000000000029999.

  PMID: 36221346 BACKGROUND

• Komasawa N, Nishihara I, Tatsumi S, Minami T. Prewarming of the i-gel facilitates successful insertion and ventilation efficacy with muscle relaxation: a randomized study. J Clin Anesth. 2014 Dec;26(8):663-7. doi: 10.1016/j.jclinane.2014.08.009. Epub 2014 Nov 18.

  PMID: 25468575 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the outcomes assessor will not know the groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: There are two models for this study. Children intubated with an endotracheal tube which 24° celcius (Group T24), Children intubated with an endotracheal tube which 37° celcius (Group T37)

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: February 20, 2025
• Study Start: March 2, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 15, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)