Airway Complications, Appendicitis Acute, Postoperative Sore Throat, Cough, Hoarseness, Respiratory Complications
Conditions
Keywords
Endotracheal tube cuff pressure, Post-anesthetic complications, Pressure transducer, Laparoscopic appendectomy, Pediatric anesthesia, Airway management, postoperative sore throat
Brief 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). 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.
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.
Interventions
DEVICEPressure 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).
PROCEDURETraditional Palpation Method
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.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This study employs a single-blind design. The attending anesthesiologist performing the intraoperative procedure and data collection is aware of the group assignment (unmasked) to ensure correct intervention and monitoring. The principal investigator, who conducts all postoperative follow-up assessments, including sore throat scoring and airway complication evaluations, remains blinded to the patient's group allocation (masked) to prevent observer bias.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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..
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Sore Throat | 24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative hoarseness. | 24 hours postoperatively | 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. |
| Intraoperative highest inspiratory pressure (Ppeak) | Throughout the duration of the surgical procedure (approx. 30-120 minutes) | 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. |
| Frequency and severity of postoperative sore throat according to postoperative time. | Measured at 2, 6, and 24 hours post-extubation. | 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. |
| Frequency of Cough at Specific Time Points Postoperatively | Measured at 2, 6, and 24 hours post-extubation | 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. |
| Incidence of postoperative cough | 24 hours postoperatively | 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. |
| Incidence of postoperative stridor | 24 hours postoperatively | 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. |
| Frequency of Hoarseness at Specific Time Points Postoperatively | Measured at 2, 6, and 24 hours post-extubation | 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. |
| Frequency of Stridor at Specific Time Points Postoperatively | Measured at 2, 6, and 24 hours post-extubation | 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. |
| Intraoperative End-tidal carbon dioxide (EtCO2) | Throughout the duration of the surgical procedure (approx. 30-120 minutes) | 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). |
| Intraoperative Leak minute ventilation (MVleak) | Throughout the duration of the surgical procedure (approx. 30-120 minutes) | 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). |
| Intraoperative Tidal volume | Throughout the duration of the surgical procedure (approx. 30-120 minutes) | 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). |
Countries
Turkey (Türkiye)
Contacts
CONTACTMuhammed Yonucu, MD, Resident in Anesthesiology
Outcome results
None listed