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Endotracheal Tube Cuff PressureNCT06321835

The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure

An observational study of Endotracheal Tube Cuff Pressure and Patient Positions, run by Ege University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: The placement of a cuffed endotracheal tube for the administration of general anesthesia is a routine procedure. In the part of the intubation tube located in the trachea, there is a balloon (cuff) to prevent gase leakage, aspiration of secretions and gastric contents into the lungs. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Endotracheal tube cuff pressure measurement
Type of treatment
Surgery or procedure
How many people
200 participants
Where
No sites listed yet
Study dates
9 Dec 2016to 15 Jun 2018
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 200 patients aged 18-75 years, ASA physical status I-II, who were planned for elective urological surgery in one of the supine, prone, lateral flank or lithotomy position were studied. The patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy

Who may be able to join

  • 200 patients aged 18-75 years
  • ASA physical status I-II
  • Who were planned for elective urological surgery in one of the supine, prone, lateral flank or lithotomy position were studied

Who cannot join

  • emergency operation
  • a history of chronic lung disease
  • upper and/or lower respiratory tract infection within 2 weeks before surgery
  • morbid obesity
  • pregnancy
  • laparoscopic surgery
Show all 10Show fewer
  • single lung ventilation
  • difficut airway
  • hemodynamic instability and/or respiratory complications in the intraoperative period
  • history of mental illness or communication problems

About this study

Official title: The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study

Background: The placement of a cuffed endotracheal tube for the administration of general anesthesia is a routine procedure. In the part of the intubation tube located in the trachea, there is a balloon (cuff) to prevent gase leakage, aspiration of secretions and gastric contents into the lungs. Inadequate inflation of cuff may lead to inadequate ventilation, aspiration and associated complications, while excessive inflation may cause complications in ranging from postoperative pharyngeal complaints to tracheal rupture due to increased cuff pressure. This study aimed to determine the effect of different patient positions on the endotracheal cuff pressure in patients undergoing urological procedures.

Methods: This is a prospective study conducted on 200 patients undergoing urological procedures in supine, prone, lateral flank and litotomy positions. After intubation (T0), the cuff pressure was checked with a cuff manometer and adjusted at 25 cmH2O as the baseline and continuously monitored. The cuff pressure was checked again before (T1) and after achieving the final position (T2) and then at 5 (T3), 10 (T4), 15 (T5), 30, 45, 60, 90, 120, 150, 180 minutes after the position, at the end of the procedure (T6) and before extubation (T7). At postoperative 2nd and 12th hours, the patients were interviewed for sore throat, hoarseness and cough.

Read the detailed description

After Institutional Review Board approval from Ege University (Ethical Committee No. 16-10/13, 09.12.2016) and written informed consent, 200 patients aged 18-75 years, ASA physical status I-II, who were planned for elective urological surgery in one of the supine, prone, lateral flank or lithotomy position were studied. The exclusion criteria were as follows: emergency operation, a history of chronic lung disease, upper and/or lower respiratory tract infection within 2 weeks before surgery, morbid obesity, pregnancy, laparoscopic surgery, single lung ventilation, difficut airway, hemodynamic instability and/or respiratory complications in the intraoperative period, history of mental illness or communication problems.

The patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy. After the patient was taken to the operating room, routine vital sign monitoring of non-invasive arterial blood pressure (NIBP), electrocardiogram (ECG) and pulse oximetry (SpO2) was performed. Oxygen mask was connected and 3 minutes %100 preoxygenation was applied. Intravenous (IV) vascular access was provided and fluid therapy was started. For induction of general anesthesia, 10 mcg/kg atropine, 1mg/kg lidocaine, 2-3 mg/kg propofol, 1-3 µg/kg fentanyl and 0,6 mg/kg rocuronium bromide were administered intravenously.

After adequate mask ventilation, female patients were intubated orotracheally with a tube of internal diameter (ID) 7-7.5mm, while male patients were intubated with a tube of ID 8-8.5mm. The equal ventilation of both lungs was confirmed by oscultation, and the position of the endotracheal tube was determined after observing the waveform of ETCO2 on the capnograph. High volume, low pressure endotracheal tubes were used for intubation. Patients who were to undergo surgery in the prone position were also intubated with a spiral tube of the same number. After intubation, the cuff of the ETT was inflated with air through an injector of 5-10 mL as a standard method, and the pressure value of the cuff after intubation (T0) was measured and recorded in a neutral head position using an analog cuff manometer (VBM Medizintechnik®, GmbH, Germany). Immediately after that, the cuff pressure was adjusted to 25 cmH2O. The manometer continuously monitored the cuff pressure without separating it from the pilot balloon of the ETT. The patient was taken volume-controlled mechanical ventilation support with a tidal volume of 6-8 mL/kg, respiratory rate of 12-16/min, and ETCO2 of 35-40 mmHg. For anesthesia maintenance, a mixture of 50% O2 and air was used, along with Sevoflurane (Sevorane Liquid 250 ml®, Abbott, UK) at 2% MAC and remifentanil infusion.

Before and after giving the patient the necessary position for the operation, the cuff pressure was measured and recorded at T1 and T2, respectively. After giving the position, attention was paid to keeping the head in a neutral position relative to the body. To prevent the effect of airway pressure on the manometer during cuff pressure measurement, the value seen at the end of expiration was recorded. Subsequently, values at 5 minutes (T3), 10 minutes (T4), 15 minutes (T5), 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, and 180 minutes were recorded during the operation. In addition, during the operation, parameters such as blood pressure, heart rate, SpO2, end-tidal CO2 (ETCO2), tidal volume, respiratory rate, mean airway pressure (MAP), and peak airway pressure (PAP) were monitored and recorded. There was no intervention in cuff pressure values during the monitoring period. Finally, after the surgical procedure was completed (T6) and before extubation after patients were put in a neutral (supine) position for waking up, cuff pressure and other parameter values were recorded. Patients were interviewed to determine if they had any complaints of sore throat, hoarseness, or cough at postoperative 2nd and 12th hours.

According to a previous study (10) the mean (SD) ETT cuff pressure was increased by 6.5 (3.9) cm H2O after the positional change from the supine to the lateral decubitus position. Assuming that the difference in the mean cuff pressure is reduced by 50% (3.25 cm H2O), we calculated that 23 patients would be needed in each group with a = 0.05 and b = 0.20. In our study, 50 patients per group were included.

The data were analyzed using the SPSS for Windows 21.0 software. Demographic data were calculated as mean standart deviation (min-max). Differences between data were analyzed using the t-test. For comparing repeated measurements, One-Way Analysis of Variance (One-Way ANOVA) was used. Post Hoc tests were used for between group comparisons. A p-value less than 0.05 was considered statistically significant.

Being tested
Endotracheal tube cuff pressure measurement
Keywords
endotracheal tube, cuff pressure, patient position, prone, lateral flank, litotomy, sore throat
Medical subject headings
Pharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endotracheal tube cuff pressure measurementProcedure or surgery

    This is a prospective study conducted on 200 patients undergoing urological procedures in supine, prone, lateral flank and litotomy positions. After intubation (T0), the cuff pressure was checked with a cuff manometer and adjusted at 25 cmH2O as the baseline and continuously monitored. The cuff pressure was checked again before (T1) and after achieving the final position (T2) and then at 5 (T3), 10 (T4), 15 (T5), 30, 45, 60, 90, 120, 150, 180 minutes after the position, at the end of the procedure (T6) and before extubation (T7). At postoperative 2nd and 12th hours, the patients were interviewed for sore throat, hoarseness and cough.

Study groups in NCT06321835
Study groupRoleWhat they receive
Supine GroupThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.
Receives: Procedure: Endotracheal tube cuff pressure measurement
Prone GroupThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.
Receives: Procedure: Endotracheal tube cuff pressure measurement
Lithotomy GroupThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.
Receives: Procedure: Endotracheal tube cuff pressure measurement
Lateral flank groupThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy.
Receives: Procedure: Endotracheal tube cuff pressure measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study

    Primary outcome of this study is endotracheal cuff pressure can be changed in patients undergoing urological procedures in different patient positions.

    Measured: 1 year

Secondary outcomes (1)
  1. The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients

    Secondary outcome of this study is the change of endotracheal cuff pressure can have effect on the postoperative pharyngolaryngeal complications

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start9 Dec 2016
  3. Primary completion15 Jan 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
200 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06321835
Sponsor's protocol ID
16-10/13
Status last verified
Mar 2024
First submitted
5 Mar 2024
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endotracheal Tube Cuff Pressure and Patient Positions, run by Ege University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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