Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy

28 giugno 2026 aggiornato da: Muhammed Yonucu, Ankara Etlik City Hospital

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.

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Muhammed Yonucu, MD, Resident in Anesthesiology
  • Numero di telefono: +905535222961
  • Email: harrenhal61@gmail.com

Luoghi di studio

  • Turchia (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turchia (Türkiye), 06010
        • Ankara Etlik City Hospital
        • Contatto:
          • Muhammed Yonucu, MD, Resident in Anesthesiology
          • Numero di telefono: 05535222961
          • Email: harrenhal61@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control Group
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.
Procedura: Traditional 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.
Altri nomi:
  • Manual cuff pressure estimation
  • Pilot balloon palpation
  • Subjective cuff inflation
  • Standard clinical cuff management
Sperimentale: Intervention Group
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).
Dispositivo: 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).
Altri nomi:
  • Invasive blood pressure monitoring set
  • Continuous cuff pressure monitoring

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Postoperative Sore Throat
Lasso di tempo: 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.
24 hours postoperatively

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of postoperative hoarseness.
Lasso di tempo: 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.
24 hours postoperatively
Intraoperative highest inspiratory pressure (Ppeak)
Lasso di tempo: 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.
Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Frequency and severity of postoperative sore throat according to postoperative time.
Lasso di tempo: 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.
Measured at 2, 6, and 24 hours post-extubation.
Frequency of Cough at Specific Time Points Postoperatively
Lasso di tempo: 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.
Measured at 2, 6, and 24 hours post-extubation
Incidence of postoperative cough
Lasso di tempo: 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.
24 hours postoperatively
Incidence of postoperative stridor
Lasso di tempo: 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.
24 hours postoperatively
Frequency of Hoarseness at Specific Time Points Postoperatively
Lasso di tempo: 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.
Measured at 2, 6, and 24 hours post-extubation
Frequency of Stridor at Specific Time Points Postoperatively
Lasso di tempo: 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.
Measured at 2, 6, and 24 hours post-extubation
Intraoperative End-tidal carbon dioxide (EtCO2)
Lasso di tempo: 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).
Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Intraoperative Leak minute ventilation (MVleak)
Lasso di tempo: 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).
Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Intraoperative Tidal volume
Lasso di tempo: 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).
Throughout the duration of the surgical procedure (approx. 30-120 minutes)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ankara Etlik City Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

3 agosto 2026

Completamento dello studio (Stimato)

25 agosto 2026

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AEŞH-EK-2026-037

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Appendicite acuta

Prove cliniche su Traditional Palpation Method

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Argentina

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi