The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range

NCT06353932 | Completed

• 1 other identifier: KA-23026
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups.

Conditions

Endotracheal Tube; Cuff Pressure; Sore Throat

Outcome Measures

Primary Outcomes (3)

• Sore throat

  Blinded researcher using VAS (The Visual Analogue Scale) score to evaluate patient discomfort level.0-no pain, score \<3 mild pain, 3-6 moderate pain, and \>6 severe pain

  second and 24th hours postoperatively

• cough

  Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has a cough, no means she/he does not

  second and 24th hours postoperatively

• hoarseness

  Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has hoarseness, no means she/he does not

  second and 24th hours postoperatively

Study Arms (2)

control group

NO INTERVENTION

The endotracheal tubes of the control group were placed and inflated by the caregiver. A seperate blinded researcher measured cuff pressures by manometer but did not inform the team and no intervention was made.

study group

ACTIVE COMPARATOR

The endotracheal tube cuff pressures of the study group patients were constantly monitored and kept within the range of 20-25 cm H2O.

Other: keeping the endotracheal tube cuff pressure within a certain range

Interventions

keeping the endotracheal tube cuff pressure within a certain range OTHER

The endotracheal tube cuff pressures of the study group patients were kept within the range of 20-25 cm H2O.

Also known as: measuring ETT cuff pressures with a manometer and continuous pressure monitor

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA ( american society of anesthesiologists) I-II-III group patients
• elective surgery
• surgery under general anesthesia
• gynecology and obstetrics and general surgery

You may not qualify if:

• Patients who did not agree to participate in the study,
• Patients under 18 years of age,
• Patients with ASA IV, V, VI,
• Patients scheduled for emergency surgery,
• Patients for whom difficult intubation is anticipated
• Patients who could not be intubated on the first try.
• Patients with tracheostomy
• Thyroidectomy operations
• Parathyroidectomy operations
• COPD (Chronic Obstructive Pulmonary Disease) patients who have had an attack in the last 6 months
• Patients who complain of sore throat, hoarseness and cough before surgery.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.

  PMID: 27158989 RESULT

• Asai S, Motoyama A, Matsumoto Y, Konami H, Imanaka H, Nishimura M. Decrease in cuff pressure during the measurement procedure: an experimental study. J Intensive Care. 2014 Jun 2;2(1):34. doi: 10.1186/2052-0492-2-34. eCollection 2014.

  PMID: 25908987 RESULT

• Liu 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.

  PMID: 20736432 RESULT

• Yildirim ZB, Uzunkoy A, Cigdem A, Ganidagli S, Ozgonul A. Changes in cuff pressure of endotracheal tube during laparoscopic and open abdominal surgery. Surg Endosc. 2012 Feb;26(2):398-401. doi: 10.1007/s00464-011-1886-8. Epub 2011 Sep 10.

  PMID: 21909860 RESULT

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Murat İzgi, Ass. Prof.

  Hacettepe University Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 9, 2024
• Study Start: January 25, 2024
• Primary Completion: February 25, 2024
• Study Completion: February 25, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All data will be kept for a year after the completion of the study

Locations

TU (1)