Postoperative Complications Related to Endotracheal IntubationNCT06043648
Continuous Endotracheal Tube Cuff Pressure Monitoring
An observational study of Postoperative Complications Related to Endotracheal Intubation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Tracheal tube cuff pressure in the range of 20 to 30 cmH2O is considered safe, but it is quite common to encounter cuff pressure outside this range in patients with tracheal intubation. Moreover, objective cuff pressure measurement and monitoring are not routinely applied, especially in general anesthesia practice. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Complications Related to Endotracheal Intubation
- What is being tested?
- Endotracheal tube cuff pressure monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 1 Jul 2023
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Adult patients scheduled for elective non-head-neck surgical procedures under N2O-free general anesthesia and orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers.
Who may be able to join
- 18-65 years of age adult patients
- Elective non-head-neck surgical procedures under nitrous oxide (N2O)-free general anesthesia
- Patients orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers
- Surgeries with neutral head-neck position
Who cannot join
- Emergency surgery
- Laparoscopic surgery
- Head and neck surgeries including nose, mouth, pharynx, larynx and throat
- Surgeries with non-supine patient position
- Patients with preoperative sore throat, cough, hoarseness or dysphagia, history of smoking, asthma or COPD, severe cardiovascular disease, inability to obtain consent, having any lesions detected in the pharynx or larynx during laryngoscopy
- Use of double lumen tracheal tube
Show all 11Show fewer
- Use of a naso- or orogastric tube or any pharyngeal catheter
- Intraoperative nitrous oxide use
- Difficult intubation or repeated endotracheal intubation attempt
- Patients who strain during endotracheal extubation
- High PEEP (greater than 5 cmH2O) application
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova University; Faculty of Medicine
Adana, Sarıçam, 01330
About this study
Official title: The Role of Continuous Endotracheal Tube Cuff Pressure Monitoring With a Simple Method in the Incidence of Endotracheal Tube-related Complications
Tracheal tube cuff pressure in the range of 20 to 30 cmH2O is considered safe, but it is quite common to encounter cuff pressure outside this range in patients with tracheal intubation. Moreover, objective cuff pressure measurement and monitoring are not routinely applied, especially in general anesthesia practice. Overinflation of the cuff can potentially impair tracheal mucosal blood flow. This may lead to various tracheal injuries such as mucosal inflammation, mucosal ischemia, tracheal ulceration, tracheal stenosis, tracheoesophageal fistula, and tracheal rupture. Conversely, inadequate cuff inflation can lead to inadequate ventilation and microaspiration. The importance of routine cuff pressure measurement and pressure adjustment to keep the pressure in the desired range is emphasized in preventing such side effects in intubated patients. Despite this recommendation for routine intracuff pressure measurement, the methods used to measure and monitor cuff pressure vary from subjective estimation techniques to objective measurements, and there is a lack of specific protocols and documents in the current literature. For this purpose, in this study, it was aimed to perform continuous cuff pressure measurement monitoring using the transducer of the invasive pressure monitoring device, which is routinely used in arterial or central venous pressure monitoring, and to test the effectiveness of this method in reducing cuff-related complications including sore throat, hoarseness, and dysphagia compared to the intermittent monitoring method.
- Being tested
- Endotracheal tube cuff pressure monitoring
- Keywords
- cuffed endotracheal tube, intracuff pressure, pressure transducer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tube cuff pressure monitoringDevice
The endotracheal tube cuff pressure was continuously monitored using a transducer from a standard invasive pressure monitoring device that is routinely used to measure arterial or central venous pressure.
| Study group | Role | What they receive |
|---|---|---|
| Constant monitoring | Intracuff pressure was monitored continuously throughout the surgery using the transducer of the invasive pressure monitoring device in patients undergoing elective non-head-neck surgical procedures under general anesthesia and orally intubated with a cuffed endotracheal tube. Receives: Device: Endotracheal tube cuff pressure monitoring | |
| Intermittent monitoring | Intracuff pressure was monitored intermittently throughout the surgery using an analogue manometer in patients undergoing elective non-head-neck surgical procedures under general anesthesia and orally intubated with a cuffed endotracheal tube. | |
| None monitoring | After endotracheal intubation with a cuffed endotracheal tube, the cuff was inflated by the anesthesia provider using sealing pressure technique which involves slow inflation of the cuff until there is no audible gas leak while holding continuous positive airway pressure of 20 cmH2O with the head and neck in the neutral position. No other intracuff pressure monitoring or measurement was performed throughout the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative sore throat
The incidence of endotracheal tube-related complication defined as sore throat during postoperative 2 and 24 hours.
Measured: Postoperative 2 and 24 hours
Incidence of postoperative hoarseness
The incidence of endotracheal tube-related complication defined as hoarseness during postoperative 2 and 24 hours.
Measured: Postoperative 2 and 24 hours
Incidence of postoperative dysphagia
The incidence of endotracheal tube-related complication defined as dysphagia during postoperative 2 and 24 hours.
Measured: Postoperative 2 and 24 hours
Secondary outcomes (1)
Identification of predictive factors related to endotracheal tube-related complications
Identification of patient and operative characteristics and mechanical ventilation related factors that influence ETT-related complications.
Measured: During postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Sep 2022
- Primary completion15 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Complications Related to Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Laflı Tunay, Cukurova University
- Investigators
- Demet Laflı Tunay, Dr., Principal investigator, Çukurova University, Balcalı Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043648
- Sponsor's protocol ID
- CUFFP
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data were anonymized by the local researcher. Therefore, data collection was pseudonymous and the patient's name did not appear on any case report form or other study document. All collected data were kept confidential. This study was conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP was strictly adhered to.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Continuous Endotracheal Tube Cuff Pressure Monitoring With a Simple Method in the Incidence of Endotracheal Tube-related Complications
- ClinicalTrials.gov ID
- NCT06043648
- Acronym / sponsor ID
- CUFFP
- Keywords
- cuffed endotracheal tube, intracuff pressure, pressure transducer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Sep 2023 (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.
Tracheal tube cuff pressure in the range of 20 to 30 cmH2O is considered safe, but it is quite common to encounter cuff pressure outside this range in patients with tracheal intubation. Moreover, objective cuff pressure measurement and monitoring are not routinely applied, especially in general anesthesia practice. Overinflation of the cuff can potentially impair tracheal mucosal blood flow. This may lead to various tracheal injuries such as mucosal inflammation, mucosal ischemia, tracheal ulceration, tracheal stenosis, tracheoesophageal fistula, and tracheal rupture. Conversely, inadequate cuff inflation can lead to inadequate ventilation and microaspiration. The importance of routine cuff pressure measurement and pressure adjustment to keep the pressure in the desired range is emphasized in preventing such side effects in intubated patients. Despite this recommendation for routine intracuff pressure measurement, the methods used to measure and monitor cuff pressure vary from subjective estimation techniques to objective measurements, and there is a lack of specific protocols and documents in the current literature. For this purpose, in this study, it was aimed to perform continuous cuff pressure measurement monitoring using the transducer of the invasive pressure monitoring device, which is routinely used in arterial or central venous pressure monitoring, and to test the effectiveness of this method in reducing cuff-related complications including sore throat, hoarseness, and dysphagia compared to the intermittent monitoring method.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Constant monitoring | – | Device: Endotracheal tube cuff pressure monitoringIntracuff pressure was monitored continuously throughout the surgery using the transducer of the invasive pressure monitoring device in patients undergoing elective non-head-neck surgical procedures under general anesthesia and orally intubated with a cuffed endotracheal tube. |
| Intermittent monitoring | – | –Intracuff pressure was monitored intermittently throughout the surgery using an analogue manometer in patients undergoing elective non-head-neck surgical procedures under general anesthesia and orally intubated with a cuffed endotracheal tube. |
| None monitoring | – | –After endotracheal intubation with a cuffed endotracheal tube, the cuff was inflated by the anesthesia provider using sealing pressure technique which involves slow inflation of the cuff until there is no audible gas leak while holding continuous positive airway pressure of 20 cmH2O with the head and neck in the neutral position. No other intracuff pressure monitoring or measurement was performed throughout the operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective non-head-neck surgical procedures under N2O-free general anesthesia and orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers.
Key inclusion criteria (4 listed)
- 18-65 years of age adult patients
- Elective non-head-neck surgical procedures under nitrous oxide (N2O)-free general anesthesia
- Patients orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers
- Surgeries with neutral head-neck position
Key exclusion criteria (11 listed)
- Emergency surgery
- Laparoscopic surgery
- Head and neck surgeries including nose, mouth, pharynx, larynx and throat
- Surgeries with non-supine patient position
- Patients with preoperative sore throat, cough, hoarseness or dysphagia, history of smoking, asthma or COPD, severe cardiovascular disease, inability to obtain consent, having any lesions detected in the pharynx or larynx during laryngoscopy
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 monitoringThe endotracheal tube cuff pressure was continuously monitored using a transducer from a standard invasive pressure monitoring device that is routinely used to measure arterial or central venous pressure. | Device | Constant monitoring |
Primary outcome
Incidence of postoperative sore throat
Time frame: Postoperative 2 and 24 hours
The incidence of endotracheal tube-related complication defined as sore throat during postoperative 2 and 24 hours.
Incidence of postoperative hoarseness
Time frame: Postoperative 2 and 24 hours
The incidence of endotracheal tube-related complication defined as hoarseness during postoperative 2 and 24 hours.
Incidence of postoperative dysphagia
Time frame: Postoperative 2 and 24 hours
The incidence of endotracheal tube-related complication defined as dysphagia during postoperative 2 and 24 hours.
1 secondary outcome
Identification of predictive factors related to endotracheal tube-related complications
Time frame: During postoperative 24 hours
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 21 Sep 2023.
- Individual participant dataSharing planned: No. All data were anonymized by the local researcher. Therefore, data collection was pseudonymous and the patient's name did not appear on any case report form or other study document. All collected data were kept confidential. This study was conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP was strictly adhered to.
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.
Demet Laflı Tunay, Dr. principal investigator
Çukurova University, Balcalı Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications Related to Endotracheal Intubation, run by Cukurova University at 1 site in Turkey (Türkiye).
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 4 inclusion and 11 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence of postoperative sore throat (time frame: Postoperative 2 and 24 hours). The study lists 3 primary outcomes in all. 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 21 Sep 2023.