Loss-of-resistance Syringe Technique in Determining Endotracheal Cuff Pressure

NCT ID: NCT05828342

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2022-10-15

Brief Summary

The goal of this observational study is to learn about whether the loss-of-resistance syringe technique is beneficial when adjusting endotracheal cuff pressure in pediatric patients.

The main questions it aims to answer are:

• Is the loss of resistance syringe technique useful when adjusting endotracheal cuff pressure in pediatric patients?
• Is there a difference between the measurements of two different cuff manometers used in the clinic, if so, what is the safety margin between the two manometers?

The participants who will be operated under general anesthesia will be anesthetized with the standard anesthesia method, the cuffs of the endotracheal tubes will be inflated with an epidural loss of resistance syringe, the syringe piston will be released, and then the syringe piston will be pushed back with oscillation. Then, cuff pressures will be measured and recorded with a cuff manometer (VBM Cuff Pressure Gauge) and an electronic injector measuring cuff pressure (AG Cufill).

Detailed Description

Various complications related to endotracheal tube may develop after general anesthesia. Inflated cuffs at inappropriately high pressure reduce tracheal mucosal blood flow, causing ischemia and tracheal stenosis in the future. Cuffs that are inflated at lower pressures than necessary can cause inadequate ventilation and aspiration of stomach contents. Adequate endotracheal cuff pressure should be between 20-30 cmH2O. Cuff pressure should be kept around 25 cmH2O in critically ill intubated and mechanically ventilated patients. In critically ill patients, such as intensive care patients, contaminated secretions can leak from the tracheal cuff and cause ventilator-associated pneumonia. High cuff pressure increases the risk of tracheomalacia and tracheal dilatation in patients who are intubated for a long time.

Inflating the endotracheal cuff at the correct pressure is the main precaution in preventing complications such as tracheal stenosis. Cuff manometers are manual or automatic devices that measure pressure in endotracheal tube (ETT) or laryngeal mask airway (LMA) cuffs, and some may operate to maintain pressure at a certain level for extended periods of time. However, it is not always possible to understand that the endotracheal cuff is inflated at the correct pressure due to operating room insufficiencies. Not every operating room has a cuff manometer, and various manual techniques are used by anesthesiologists to inflate the endotracheal cuff without a cuff manometer. One of these techniques is the palpation technique applied by experienced anesthesiologists. However, this technique is known to have a high rate of errors. It has been shown that professional experience does not contribute to achieving the correct cuff pressure without pressure monitoring. Another technique is the "loss of resistance syringe technique". It aims to equalize the endotracheal cuff pressure to the tracheal lateral wall pressure by releasing the syringe piston after inflating the endotracheal cuff with a loss of resistance syringe, allowing the air pressure inside the cuff to push the syringe piston passively. This technique has been used previously in adult patients and has been proposed as an economical and easily accessible method for inflating the endotracheal cuff. There is no study in the literature on the use of this technique in pediatric patients.

In this study, investigators aimed to find out whether the resistance loss syringe technique is useful when adjusting the endotracheal cuff pressure in pediatric patients. Secondary aim of the study is to evaluate the measurements of two different manometers and to determine the margin of safety between the two manometers.

Benefit from research; the aim is to facilitate the inflation of the endotracheal cuffs of pediatric patients intubated under general anesthesia at the correct pressure and to prevent possible complications. The study does not have any risks other than possible general anesthesia risks.

This study is a clinical observational prospective study. Participants were patients between the ages of 0-18 who were anesthetized with standard general anesthesia method in the pediatric operating room and intubated with a cuffed endotracheal tube. Then, the cuff of the endotracheal tubes will be inflated with the epidural loss of resistance syringe, after that the syringe piston will be released, the syringe piston will be pushed back by the cuff pressure, and then the cuff pressures will be measured and recorded with the cuff manometer (VBM Cuff Pressure Gauge) and the cuff pressure measuring electronic injector (AG Cufill). A three-way vein valve will be used when making this measurement. During the measurement, an epidural loss of resistance syringe will be attached to one valve, a cuff manometer attached to another valve, and an electronic injector (AG Cufill) measuring cuff pressure to the third track. With this technique, the possibility of leakage due to insertion and removal during measurements will be eliminated. The tube number of the patients will be determined according to the age-based formula and according to the anesthetist's prediction during intubation. Then it will be checked whether there is an air leak in the mechanical ventilator. The endotracheal tube cuff of patients with airway leakage will be inflated under the guidance of the cuff manometer so that there is no leakage.

Conditions

Endotracheal Tube Cuff Pressure; Loss of Resistance Syringe; Airway Edema; Pediatric Population

Keywords

Airway; Cuff Pressure; Endotracheal Tube

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric Patients

Patients under the age of 18 who were operated under general anesthesia and intubated with a cuffed endotracheal tube between 15 July 2022 and 15 October 2022 in the pediatric operating room.

Endotracheal tube cuff inflation with the loss of resistance syringe method

Intervention Type: PROCEDURE

The cuffs of the endotracheal tubes will be inflated with the epidural loss of resistance syringe, the syringe piston will be released, the syringe piston will be pushed back with oscillation, and then the cuff pressures will be measured and recorded with a cuff manometer (VBM Cuff Pressure Gauge) and an electronic injector that measures cuff pressure (AG Cufill). A three-way vein valve will be used when making this measurement. During the measurement, an epidural resistance loss injector will be attached to one valve, a cuff manometer attached to another valve, and an electronic injector (AG Cufill) measuring cuff pressure to the third track. With this technique, the possibility of leakage due to insertion and removal during measurements will be eliminated.

Interventions

Endotracheal tube cuff inflation with the loss of resistance syringe method

The cuffs of the endotracheal tubes will be inflated with the epidural loss of resistance syringe, the syringe piston will be released, the syringe piston will be pushed back with oscillation, and then the cuff pressures will be measured and recorded with a cuff manometer (VBM Cuff Pressure Gauge) and an electronic injector that measures cuff pressure (AG Cufill). A three-way vein valve will be used when making this measurement. During the measurement, an epidural resistance loss injector will be attached to one valve, a cuff manometer attached to another valve, and an electronic injector (AG Cufill) measuring cuff pressure to the third track. With this technique, the possibility of leakage due to insertion and removal during measurements will be eliminated.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-Patients under the age of 18 who will be intubated and operated under general anesthesia in the pediatric operating room, whose informed consent form has been approved by their parents, between July 15, 2022 and October 15, 2022

Exclusion Criteria

• Patients who are considered for difficult intubation, trachamalacia, laryngomalacia, tracheal surgery, or whose parental consent form has not been approved will be excluded from the study.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Yusuf Yılmaz

Specialist Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sengul Ozmert

Role: STUDY_DIRECTOR

Ankara CH Bilkent

Ayça T Dumanlı Ozcan

Role: STUDY_DIRECTOR

Ankara CH Bilkent

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Nseir S, Brisson H, Marquette CH, Chaud P, Di Pompeo C, Diarra M, Durocher A. Variations in endotracheal cuff pressure in intubated critically ill patients: prevalence and risk factors. Eur J Anaesthesiol. 2009 Mar;26(3):229-34. doi: 10.1097/eja.0b013e3283222b6e.

Reference Type: BACKGROUND

PMID: 19244697 (View on PubMed)

Weiss M, Doell C, Koepfer N, Madjdpour C, Woitzek K, Bernet V. Rapid pressure compensation by automated cuff pressure controllers worsens sealing in tracheal tubes. Br J Anaesth. 2009 Feb;102(2):273-8. doi: 10.1093/bja/aen355. Epub 2008 Dec 25.

Reference Type: BACKGROUND

PMID: 19112060 (View on PubMed)

Dubey M, Kumar Mittal A, Choudhary M. Loss of Resistance Syringe: A Substitute for Cuff Pressure Manometer. Anesth Analg. 2017 Aug;125(2):701-703. doi: 10.1213/ANE.0000000000002235. No abstract available.

Reference Type: BACKGROUND

PMID: 28737520 (View on PubMed)

Other Identifiers

E2-22-2060

Identifier Type: -

Identifier Source: org_study_id