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Completed

NCT Number: NCT06838260

Assessment of Endotracheal Tube Temperature Effects in Children Undergoing Adenotonsillectomy

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.

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Key information

Conditions

Adenotonsillectomy

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

About this study

Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children. Its incidence has been increasing day by day and has almost doubled since the 1970s. In recent years, with the development of surgical techniques and anesthetic approaches, significant progress has been made in the recovery and postoperative management of these patients and morbidity has decreased significantly. The most feared complications of AT in children are respiratuar complications such as laryngospasm and bronchospasm. These complications can occur during AT or in the postoperative period, requiring rapid response by the anesthesia and surgical team and extensive postoperative monitoring. They may result in increased morbidity and prolonged hospitalization. Different methods including intravenous lidocaine, topical lidocaine, propofol, iv magnesium and the like have been proposed to reduce laryngospasm; different results have been obtained in studies. Thermal softening of endotracheal tubes (ETT) with normal warm saline before intubation has been shown to be significantly effective in reducing sore throat and hoarseness during recovery and postoperatively. The aim of this study was to compare the intraoperative and postoperative respiratory effects of using endotracheal intubation tubes at different temperatures during intubation in children undergoing adenotonsillectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Rate of laryngospasm

    Time frame: From extubation until postoperative 2. hour

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

  2. Rate of bronchospasm

    Time frame: From extubation until postoperative 2. hour

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

  3. Rate of desaturation

    Time frame: From extubation until postoperative 2. hour

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

Secondary outcomes

  1. Heart rate

    Time frame: 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)

    Heart rate (HR) (bpm) will be recorded and data will be compared between groups

  2. Mean arterial pressure (MAP) mmHg

    Time frame: 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) will be recorded and data will be compared between groups

  3. Oxygen saturation

    Time frame: 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 (SpO2), (%) will be recorded and data will be compared between groups

  4. Intraopearative anaesthesia machine respiratory data

    Time frame: 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)

    End-tidal carbon dioxide (EtCO2) (mmHg) will be recorded and data will be compared between groups

  5. Intraopearative anaesthesia machine respiratory data 2

    Time frame: 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)

    Maximum pressure measured at end inspiration (Ppeak) will be recorded and data will be compared between groups Mean airway pressure (Pmean) will be recorded and data will be compared between groups

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

Assessment of the Effects of Endotracheal Tube Temperature on Respiratory Complications in Children Undergoing Adenotonsillectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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