An interventional study of Pressure Transducer and Traditional Palpation Method in Appendicitis Acute, Postoperative Sore Throat, Cough, Hoarseness and Airway Complications, sponsored by Ankara Etlik City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Prevention
Abstract Objective:
The aim of this study is to compare two different ways of adjusting the air-filled cushion (cuff) of the breathing tube used during general anesthesia in children undergoing laparoscopic appendectomy (closed surgery for appendicitis). The goal is to see if maintaining the pressure in this cushion within a safe, specific range (15-18 mmHg) helps prevent or reduce sore throat, hoarseness, and discomfort, which are common postoperative complications in children.
Study Design:
This is a prospective, randomized, controlled study. Sixty children aged 6 to 18 years scheduled for laparoscopic appendectomy will be included. Participants will be randomly assigned to two equal groups: Group A (Control Group): Breathing tube cuff pressure is adjusted using the standard "feeling" (finger palpation) method common in routine practice. Group B (Intervention Group): Breathing tube cuff pressure is measured throughout the surgery using a medical pressure sensor (manometer) and maintained within a safe range (15-18 mmHg). Research Questions: Does actively monitoring airway pressure reduce the number of children experiencing postoperative sore throat? Does this method reduce the severity of sore throat, cough, hoarseness, or other respiratory discomfort compared to the standard method? What will happen?
During surgery, respiratory and heart rate measurements will be recorded every 15 minutes for all participants. After surgery, researchers will visit participants (and their parents) at 2, 6, and 24 hours postoperatively to assess the presence of sore throat, discomfort, or hoarseness. No additional medications or invasive procedures will be used for this study; only how we manage airway pressure will be compared.
Endotracheal tube (ETT) placement is a critical component of pediatric general anesthesia. In pediatric patients, the tracheal mucosa is highly sensitive to pressure. If the ETT cuff pressure exceeds the mucosal capillary perfusion pressure, it can lead to ischemic damage and subsequent postoperative airway morbidities such as postoperative sore throat (POST), cough, and hoarseness.
During laparoscopic surgeries such as appendectomy, the creation of pneumoperitoneum and the necessary surgical positioning increase intra-abdominal and intrathoracic pressures. These physiological changes dynamically increase the peak airway pressure (Ppeak) and the corresponding ETT cuff pressure, making optimal cuff pressure management clinically challenging.
Traditionally, cuff pressure is subjectively adjusted by the anesthesiologist using a pilot balloon palpation technique. However, evidence suggests that this method often leads to undetectable and unsafe high pressures. Alternatively, continuous objective monitoring of endotracheal tube (ETT) cuff pressure using an invasive arterial blood pressure transducer setup offers a real-time method for maintaining pressure within a safe physiological range (15-18 mmHg).
This prospective, randomized controlled trial aims to investigate whether continuous objective monitoring and titration of ETT cuff pressure via a pressure transducer, compared to conventional subjective palpation, can optimize intraoperative respiratory mechanics and reduce the frequency and severity of postoperative upper respiratory tract complications in pediatric patients undergoing laparoscopic appendectomy.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 60 is below the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Ankara Etlik City Hospital is the lead sponsor of 176 studies on the registry; 77 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group of patients, endotracheal tube cuff pressure was adjusted using the traditionally used and subjective finger palpation technique of the endotracheal tube pilot balloon.
Procedure: Traditional Palpation Method
In this group of patients, endotracheal tube cuff pressure was continuously monitored using a pressure transducer from an invasive arterial pressure measurement set and maintained within a safe range (15-18 mmHg).
Device: Pressure Transducer
In this group of patients, endotracheal tube cuff pressure was continuously monitored using a pressure transducer from an invasive arterial pressure measurement set and maintained within a safe range (15-18 mmHg).
Also known as: Invasive blood pressure monitoring set, Continuous cuff pressure monitoring
The endotracheal tube cuff pressure was adjusted by the anesthesiologist using the subjective manual palpation technique, where the pressure in the cuff was estimated by manually squeezing the pilot balloon. No external monitoring device was used in this group, reflecting the conventional clinical practice.
Also known as: Manual cuff pressure estimation, Pilot balloon palpation, Subjective cuff inflation, Standard clinical cuff management
Incidence of Postoperative Sore Throat
The incidence of sore throat in patients during the first 24 hours after surgery will be evaluated and compared between groups. Sore throat is defined as pain or discomfort felt in the larynx or pharynx, often worsened by swallowing. It will be evaluated as yes/no.
Time frame: 24 hours postoperatively
Incidence of postoperative hoarseness.
The frequency of hoarseness will be assessed and compared between groups within the first 24 hours after surgery. Hoarseness will be defined as an abnormal change in the voice, such as the voice sounding breathy, muffled, strained, or a change in loudness or pitch. It will be evaluated as yes/no.
Time frame: 24 hours postoperatively
Intraoperative highest inspiratory pressure (Ppeak)
The highest inspiratory pressure (Ppeak) (mmHg) measured after intubation (T0), after pneumoperitoneum (T1), and every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te) will be recorded and compared between groups.
Time frame: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Frequency and severity of postoperative sore throat according to postoperative time.
Assessment of the presence and severity of sore throat after extubation. Severity is scored using a 4-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Comparisons will be made between groups after the assessment.
Time frame: Measured at 2, 6, and 24 hours post-extubation.
Frequency of Cough at Specific Time Points Postoperatively
Postoperative cough will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation. It will be evaluated as yes/no.
Time frame: Measured at 2, 6, and 24 hours post-extubation
Incidence of postoperative cough
The frequency of cough will be assessed and compared between groups within the first 24 hours after surgery. It will be evaluated as yes/no.
Time frame: 24 hours postoperatively
Incidence of postoperative stridor
The frequency of stridor will be assessed and compared between groups within the first 24 hours after surgery. In a situation where the patient is pain-free (calm), airway secretions are completely cleared, and there is no anatomical/residual airway obstruction, a new, high-pitched inspiratory sound that occurs after extubation will be considered stridor. It will be evaluated as yes/no.
Time frame: 24 hours postoperatively
Frequency of Hoarseness at Specific Time Points Postoperatively
Postoperative hoarseness will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation. It will be evaluated as yes/no. Hoarseness will be defined as an abnormal change in the voice, such as the voice sounding breathy, muffled, strained, or a change in loudness or pitch.
Time frame: Measured at 2, 6, and 24 hours post-extubation
Frequency of Stridor at Specific Time Points Postoperatively
Postoperative stridor will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation. It will be evaluated as yes/no. In a situation where the patient is pain-free (calm), airway secretions are completely cleared, and there is no anatomical/residual airway obstruction, a new, high-pitched inspiratory sound that occurs after extubation will be considered stridor.
Time frame: Measured at 2, 6, and 24 hours post-extubation
Intraoperative End-tidal carbon dioxide (EtCO2)
End-tidal carbon dioxide (EtCO2) (mmHg) will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).
Time frame: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Intraoperative Leak minute ventilation (MVleak)
Leak minute ventilation (MVleak) (L/minute) values will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).
Time frame: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Intraoperative Tidal volume
Tidal volume (ml) values will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).
Time frame: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Plan to share: No — The individual participant data collected during the study are considered confidential institutional data according to the study protocol and informed consent forms approved by the local ethics committee. The data will only be available to authorized regulatory bodies and the investigation team to ensure participant privacy and data security.
Start is estimated for Jun 2026; primary completion for Aug 2026, 1 month later.
Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 1 month is below that.
Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
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