Appendicitis AcuteNCT07678086
Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy
A study testing Pressure Transducer and Traditional Palpation Method in people with Appendicitis Acute and Postoperative Sore Throat, Cough, Hoarseness, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Appendicitis Acute, Postoperative Sore Throat, Cough, Hoarseness, Airway Complications
- What is being tested?
- Pressure Transducer and Traditional Palpation Method
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2026to 25 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged 6-18 years
- Patients with ASA physical status classification I-III
- Patients scheduled for laparoscopic appendectomy
- Voluntary written informed consent from the patient's legal guardian/parent after being informed in detail about the purpose and method of the study..
Who cannot join
- Patients under 6 years of age
- Patients with ASA IV or higher
- Patients with preoperative sore throat
- Patients who have not completed the preoperative fasting period
- Patients who received intraoperative nasogastric tube
- Patients who received intraoperative N₂O
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- Patients with complicated appendicitis diagnosis
- Patients who underwent two or more intubation attempts
- Patients with surgery duration longer than 2 hours
- Patients with predicted or likely airway difficulties
- Patients who underwent conversion from intraoperative laparoscopy to laparotomy
- Presence of tracheal pathology
- Congenital anomalies affecting the airway
- Presence of known upper/lower respiratory tract disease
- Patients requiring planned postoperative mechanical ventilation
- Patients in shock
- Patients with decompensated heart failure or respiratory failure
- Patient or legal representative's refusal to participate in the study
- Patients with a history of smoking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
Muhammed Yonucu, MD, Resident in Anesthesiology, 05535222961, harrenhal61@gmail.com
About this study
Official title: The Effect of Intraoperative Endotracheal Tube Cuff Pressure on Postoperative Sore Throat in Pediatric Patients Undergoing Laparoscopic Appendectomy: A Prospective Randomized Controlled Trial.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Appendicitis Acute, Postoperative Sore Throat, Cough, Hoarseness, Airway Complications, Respiratory Complications
- Being tested
- Pressure Transducer, Traditional Palpation Method
- Keywords
- Endotracheal tube cuff pressure, Post-anesthetic complications, Pressure transducer, Laparoscopic appendectomy, Pediatric anesthesia, Airway management, postoperative sore throat
- Medical subject headings
- Appendicitis, Cough, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure TransducerDevice
Also called Invasive blood pressure monitoring set, Continuous cuff pressure monitoring
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).
Traditional Palpation MethodProcedure or surgery
Also called Manual cuff pressure estimation, Pilot balloon palpation, Subjective cuff inflation, Standard clinical cuff management
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Procedure: Traditional Palpation Method |
| Intervention Group | Experimental | 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). Receives: Device: Pressure Transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion3 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study has a parallel-group, prospective, randomized, controlled design. Patients undergoing laparoscopic appendectomy are assigned to groups in a 1:1 ratio by drawing numbers from a opaque bag containing numbers from 1 to 60. Odd numbers are assigned to Group A, where endotracheal tube (ETT) cuff pressure is adjusted by subjective palpation. Even numbers are assigned to Group B, where ETT cuff pressure is objectively monitored via a pressure transducer and maintained within a safe range (15-18 mmHg). Participants remain in their assigned groups for the entire intraoperative and postoperative follow-up period. Patients who meet pre-defined exclusion criteria during surgery (such as conversion to laparotomy, complicated appendicitis, or procedure duration exceeding 2 hours) are removed from the study, and their assigned numbers are re-randomized. All patients follow the same standardized anesthesia and surgical protocol; the only difference is the method of cuff pressure management.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammed Yonucu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678086
- Sponsor's protocol ID
- AEŞH-EK-2026-037
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ban MG, Kim SY, Kim MS, Park WK, Kwon YI, Kim HJ. Accuracy of pilot balloon palpation for cuff pressure assessment in small versus large sized tubes: a prospective non-randomized observational study. Sci Rep. 2023 Apr 5;13(1):5580. doi: 10.1038/s41598-023-32704-3.
PubMed 37020098Ganason N, Sivanaser V, Liu CY, Maaya M, Ooi JSM. Post-operative Sore Throat: Comparing the Monitored Endotracheal Tube Cuff Pressure and Pilot Balloon Palpation Methods. Malays J Med Sci. 2019 Sep;26(5):132-138. doi: 10.21315/mjms2019.26.5.12. Epub 2019 Nov 4.
PubMed 31728125Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.
PubMed 20736432Wang C, Yan X, Gao C, Liu S, Bao D, Zhang D, Jiang J, Wu A. Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial. J Clin Monit Comput. 2024 Dec;38(6):1379-1386. doi: 10.1007/s10877-024-01173-y. Epub 2024 May 11.
PubMed 38733506