Intubation ComplicationNCT04466995
Factors Affecting Endotracheal Cuff Pressure in Gynecological Cases
A study testing manometer in people with Intubation Complication, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative airway complications associated with endotracheal intubation can be seen. While some of these complications are predictable, some may occur urgently. If the endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from mucosal pressure is one of the main factors for tracheal… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Intubation Complication
- What is being tested?
- manometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2020to 1 Jun 2021
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients between 18-70 years old who will undergo gynecological abdominal surgery
- Patients with American Society of Anesthesiologists physical status 1-3
- Patients who will undergo elective surgery
Who cannot join
- Patients with tracheotomy
- Patients with detected tracheal stenosis
- Patients with laryngeal disease or laryngeal surgery
- Patients with difficult airway (intubated after 2 or more attempts)
- Patients with BMI> 35
- Patients receiving chronic obstructive pulmonary disease treatment
- Patients with ASA ≥4
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Bakirkoy
About this study
Official title: Factors Affecting Endotracheal Cuff Pressure in Laparoscopic and Laparotomic Gynecological Cases and Its Effect on Postoperative Respiratory Complications
Postoperative airway complications associated with endotracheal intubation can be seen.
While some of these complications are predictable, some may occur urgently. If the endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from mucosal pressure is one of the main factors for tracheal morbidity. Endotracheal tube cuff pressure is not routinely measured. It was confirmed that the palpation of the pilot balloon was insufficient to detect high cuff pressures. In laparoscopic cases, the investigators aimed to investigate whether the increase in intra-abdominal pressure as a result of carbon dioxide insufflation, and the change of respiratory functions after trendelenburg position are effective on cuff pressure and whether there is a difference compared to laparotomic cases.
Read the detailed description
It was planned to include 50 patients in the American Anesthesiologists Association (ASA) 1-3 risk score group, which will be an elective gynecological operation between the ages of 18-70. When patients arrive in the operating room, after the ECG, pulse oximeter, non-invasive pressure monitoring is provided in the supine position, 18 gauge intravenous(iv) vascular access will be opened and balanced fluid 4-6 ml / kg / h will be inserted. Anesthesia induction with midazolam 0.05 mg / kg, propofol 2-3 mg / kg, Fentanyl 1-2 µg / kg and rocuronium 0.6 mg / kg will be achieved after 3 minutes of preoxygenation. he muscle relaxant effect will be monitored by monitoring TOF (train of four), and after sufficient relaxation (TOF 95%), the anesthetist will be intubated with the 7-7.5 number endotracheal tube suitable for the high-volume low-pressure patient. The cuff of the endotracheal tube will be inflated with the help of an injector and the cuff will be attached to the manometer. Cuff pressures will be inflated to 25 mmHg. The patients will be given oxygen at 40% and air at 3lt / min. The maintenance of anesthesia will be achieved with sevoflurane and 0.05-0.1mcg / kg / min remifentanil infusion.
If the patient feels pain in the perioperative period, 50 mcg fentanyl iv will be used as rescue analgesia. During the operation, rokurunium (0.2mg / kg) boluses will be delivered according to the patient's clinic and the TOF value between 0-2 (depending on the type of surgery). Mechanical ventilation will be started in volume controlled mode with 6-8 ml / kg tidal volume, and 12 frequencies. Respiratory frequencies,tidal volume and positive end expiratory pressure (PEEP) values of patients will be optimized so that end tidal CO2 is 35-45 mmHg throughout the case. At the end of surgery, 100 mg tramadol and 1 g paracetamol will be administered to patients for the purpose of postoperative analgesia. Patients will be extubated after the muscle relaxant is recurrentized with 0.03mg / kg neostigmine and 0.01mg / kg atropine.
If the patient's numeric rating scale (NRS) score is 3 or more during recovery, 0.3 mg / kg Petidine hydrochloride will be applied as rescue analgesia. The 'Case Tracking Form' prepared for the follow-up of the research will be recorded demographically, age, height, weight and BMI information of the patients in the preoperative period.
In the perioperative period, cuff pressures in the supine position after intubation, at the 5th, 15th, 30th, 45th minutes and before extubation will be measured and recorded with the cuff manometer. In addition to the follow-up form, intra-abdominal pressure, PEEP, P peak and P plateau values, anesthesia time, operation time during each measurement will be recorded. Patients who were followed-up in the recovery were evaluated by the service nurse who did not know how to work in the service at the postoperative 1st, 12th, 24th hours, and the NRS (numeric rating scale) (0 is painless, 10 is the most painful and will be asked to describe the pain from 1 to 10); It will be evaluated in terms of dysphagia, cough, sore throat, hoarseness.
- Conditions
- Intubation Complication
- Being tested
- manometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manometerDevice
cuff pressure to be measured with manometer
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic gynecologic surgery | Experimental | 25 laparoscopic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded Receives: Device: manometer |
| laparotomic gynecologic surgery | Other | 25 laparotomic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded Receives: Device: manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
cuff pressure
cuff pressure to be measured with manometer
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start5 Feb 2020
- Primary completion1 Jan 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Endotracheal tube pressure will be measured in the surgical technique using 2 different methods.(laparoscopic and laprotomic)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Güneş Özlem Yıldız, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- gunes o yildiz, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466995
- Sponsor's protocol ID
- 2020/92
- Status last verified
- Jan 2022
- First submitted
- 5 Jun 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Endotracheal Cuff Pressure in Laparoscopic and Laparotomic Gynecological Cases and Its Effect on Postoperative Respiratory Complications
- ClinicalTrials.gov ID
- NCT04466995
- Acronym / sponsor ID
- 2020/92
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 10 Jul 2020 (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.
Postoperative airway complications associated with endotracheal intubation can be seen.
While some of these complications are predictable, some may occur urgently. If the endotracheal cuff is over-inflated and its pressure is high, mucosal damage resulting from mucosal pressure is one of the main factors for tracheal morbidity. Endotracheal tube cuff pressure is not routinely measured. It was confirmed that the palpation of the pilot balloon was insufficient to detect high cuff pressures. In laparoscopic cases, the investigators aimed to investigate whether the increase in intra-abdominal pressure as a result of carbon dioxide insufflation, and the change of respiratory functions after trendelenburg position are effective on cuff pressure and whether there is a difference compared to laparotomic cases.
Detailed description
It was planned to include 50 patients in the American Anesthesiologists Association (ASA) 1-3 risk score group, which will be an elective gynecological operation between the ages of 18-70. When patients arrive in the operating room, after the ECG, pulse oximeter, non-invasive pressure monitoring is provided in the supine position, 18 gauge intravenous(iv) vascular access will be opened and balanced fluid 4-6 ml / kg / h will be inserted. Anesthesia induction with midazolam 0.05 mg / kg, propofol 2-3 mg / kg, Fentanyl 1-2 µg / kg and rocuronium 0.6 mg / kg will be achieved after 3 minutes of preoxygenation. he muscle relaxant effect will be monitored by monitoring TOF (train of four), and after sufficient relaxation (TOF 95%), the anesthetist will be intubated with the 7-7.5 number endotracheal tube suitable for the high-volume low-pressure patient. The cuff of the endotracheal tube will be inflated with the help of an injector and the cuff will be attached to the manometer. Cuff pressures will be inflated to 25 mmHg. The patients will be given oxygen at 40% and air at 3lt / min. The maintenance of anesthesia will be achieved with sevoflurane and 0.05-0.1mcg / kg / min remifentanil infusion.
If the patient feels pain in the perioperative period, 50 mcg fentanyl iv will be used as rescue analgesia. During the operation, rokurunium (0.2mg / kg) boluses will be delivered according to the patient's clinic and the TOF value between 0-2 (depending on the type of surgery). Mechanical ventilation will be started in volume controlled mode with 6-8 ml / kg tidal volume, and 12 frequencies. Respiratory frequencies,tidal volume and positive end expiratory pressure (PEEP) values of patients will be optimized so that end tidal CO2 is 35-45 mmHg throughout the case. At the end of surgery, 100 mg tramadol and 1 g paracetamol will be administered to patients for the purpose of postoperative analgesia. Patients will be extubated after the muscle relaxant is recurrentized with 0.03mg / kg neostigmine and 0.01mg / kg atropine.
If the patient's numeric rating scale (NRS) score is 3 or more during recovery, 0.3 mg / kg Petidine hydrochloride will be applied as rescue analgesia. The 'Case Tracking Form' prepared for the follow-up of the research will be recorded demographically, age, height, weight and BMI information of the patients in the preoperative period.
In the perioperative period, cuff pressures in the supine position after intubation, at the 5th, 15th, 30th, 45th minutes and before extubation will be measured and recorded with the cuff manometer. In addition to the follow-up form, intra-abdominal pressure, PEEP, P peak and P plateau values, anesthesia time, operation time during each measurement will be recorded. Patients who were followed-up in the recovery were evaluated by the service nurse who did not know how to work in the service at the postoperative 1st, 12th, 24th hours, and the NRS (numeric rating scale) (0 is painless, 10 is the most painful and will be asked to describe the pain from 1 to 10); It will be evaluated in terms of dysphagia, cough, sore throat, hoarseness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Endotracheal tube pressure will be measured in the surgical technique using 2 different methods.(laparoscopic and laprotomic)
| Arm | Type | Receives |
|---|---|---|
| laparoscopic gynecologic surgery | Experimental | Device: manometer25 laparoscopic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded |
| laparotomic gynecologic surgery | Other | Device: manometer25 laparotomic surgery to endotracheal cuff pressure 5., 15., 30., 45. min will be measured, values will be recorded |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients between 18-70 years old who will undergo gynecological abdominal surgery
- Patients with American Society of Anesthesiologists physical status 1-3
- Patients who will undergo elective surgery
Key exclusion criteria (7 listed)
- Patients with tracheotomy
- Patients with detected tracheal stenosis
- Patients with laryngeal disease or laryngeal surgery
- Patients with difficult airway (intubated after 2 or more attempts)
- Patients with BMI> 35
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 |
|---|---|---|
| manometercuff pressure to be measured with manometer | Device | laparoscopic gynecologic surgery, laparotomic gynecologic surgery |
Primary outcome
cuff pressure
Time frame: 1 hour
cuff pressure to be measured with manometer
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 1 Feb 2022.
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Recruiting
The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
gunes o yildiz principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manometer in people with Intubation Complication, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 3 inclusion and 7 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 1 Feb 2022. 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?
cuff pressure (time frame: 1 hour). 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 1 Feb 2022.