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Assessment of Endotracheal Tube Temperature Effects in Children Undergoing Adenotonsillectomy

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06838260
Enrollment
270
Registered
2025-02-20
Start date
2025-03-02
Completion date
2026-03-15
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillectomy

Keywords

Adenotonsillectomy in children, Endotracheal tube temperature, Respiratory complications

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.

Detailed description

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.

Interventions

OTHER24°C Endotracheal tube

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.

OTHER37°C Endotracheal tube

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.

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient and the outcomes assessor will not know the groups

Intervention model description

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)

Eligibility

Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of laryngospasmFrom extubation until postoperative 2. hourThe rates of laryngospasm occurring in the participants will be determined and compared between the 2 groups
Rate of bronchospasmFrom extubation until postoperative 2. hourThe rates of bronchospasm occurring in the participants will be determined and compared between the 2 groups
Rate of desaturationFrom extubation until postoperative 2. hourThe rates of desaturation occurring in the participants will be determined and compared between the 2 groups

Secondary

MeasureTime frameDescription
Heart rate7 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
Mean arterial pressure (MAP) mmHg7 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
Oxygen saturation7 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
Intraopearative anaesthesia machine respiratory data4 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
Intraopearative anaesthesia machine respiratory data 24 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 13, 2026