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

4 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Muhammed Yonucu, MD, Resident in Anesthesiology
  • Telefoonnummer: +905535222961
  • E-mail: harrenhal61@gmail.com

Studie Locaties

  • Turkije (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkije (Türkiye), 06010
        • Werving
        • Ankara Etlik City Hospital
        • Contact:
          • Muhammed Yonucu, MD, Resident in Anesthesiology
          • Telefoonnummer: 05535222961
          • E-mail: harrenhal61@gmail.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Procedure: 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.
Andere namen:
  • Manual cuff pressure estimation
  • Pilot balloon palpation
  • Subjective cuff inflation
  • Standard clinical cuff management
Experimenteel: 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).
Apparaat: 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).
Andere namen:
  • Invasive blood pressure monitoring set
  • Continuous cuff pressure monitoring

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Postoperative Sore Throat
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of postoperative hoarseness.
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ankara Etlik City Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juni 2026

Primaire voltooiing (Geschat)

3 augustus 2026

Studie voltooiing (Geschat)

25 augustus 2026

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

4 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AEŞH-EK-2026-037

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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