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.
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
- Conditions the study is for
- Endotracheal Tube Cuff Pressure, Patient Positions
- 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.
- Conditions
- Endotracheal Tube Cuff Pressure, Patient Positions
- 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 group | Role | What they receive |
|---|---|---|
| Supine Group | The 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 Group | The 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 Group | The 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 group | The 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.
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)
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.
- First posted20 Mar 2024
- Study start9 Dec 2016
- Primary completion15 Jan 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube Cuff PressureStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursen Karaca, Ege University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study
- ClinicalTrials.gov ID
- NCT06321835
- Acronym / sponsor ID
- 16-10/13
- Conditions
- Endotracheal Tube Cuff Pressure, Patient Positions
- Keywords
- endotracheal tube, cuff pressure, patient position, prone, lateral flank, litotomy, sore throat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supine Group | – | Procedure: Endotracheal tube cuff pressure measurementThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy. |
| Prone Group | – | Procedure: Endotracheal tube cuff pressure measurementThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy. |
| Lithotomy Group | – | Procedure: Endotracheal tube cuff pressure measurementThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy. |
| Lateral flank group | – | Procedure: Endotracheal tube cuff pressure measurementThe patients were divided into four groups according to the operation position as supine, lateral flank, prone and lithotomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- emergency operation
- a history of chronic lung disease
- upper and/or lower respiratory tract infection within 2 weeks before surgery
- morbid obesity
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal tube cuff pressure measurementThis 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. | Procedure or surgery | Lateral flank group, Lithotomy Group, Prone Group, Supine Group |
Primary outcome
The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients Undergoing Urological Procedures: A Prospective Study
Time frame: 1 year
Primary outcome of this study is endotracheal cuff pressure can be changed in patients undergoing urological procedures in different patient positions.
1 secondary outcome
The Effect of Different Patient Positions on Endotracheal Tube Cuff Pressure in Patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.