AnesthesiaNCT06356649
Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes During Extubation
An observational study of Anesthesia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- extubation
- Type of treatment
- Surgery or procedure
- How many people
- 199 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 20 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing laparoscopic anesthesia with general anesthesia
Who may be able to join
- Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study
Who cannot join
- The patient does not want to participate in the study.
- Known advanced lung disease, advanced-stage heart disease
- Switching from laparoscopic surgery to open surgery
- Surgical procedure exceeds 120 minutes
- intraoperative bleeding >500 ml
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Medical Faculty
Eskişehir, Odunpazarı, 26040
About this study
Official title: Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes on Respiratory System Complications During Extubation
Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications.
Read the detailed description
After informed consent was obtained from the patients, monitoring was performed as we practice in routine anesthesia practice. Pressure controlled ventilation (PCV) mode and positive end-expiratory pressure (PEEP) were used as the mechanical ventilation mode after intubation. After the operation was completed, PCV mode on the mechanical ventilator was continued until the patient was extubated. Afterwards, patients were extubated if they complied with verbal commands and/or swallowed and/or coughed in response to vocal stimuli, pupils were in the midline and conjugated, BIS value was >80, breathing was regular, and TOF response was >90%. Hemodynamic and respiratory system complications were recorded during the intraoperative, recovery-extubation and postoperative periods. Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study. In the preoperative period, the patient's demographic data and hemodynamic data, and in the intraoperative period, respiratory data (tidal volume, pressure applied during inspiration, peep, etc.) and hemodynamic data were recorded. Complications recorded during recovery-extubation; desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.
- Conditions
- Anesthesia
- Being tested
- extubation
- Keywords
- pressure controlled ventilation, positive end-expiratory pressure, tracheal extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extubationProcedure or surgery
Complications after extubation
| Study group | Role | What they receive |
|---|---|---|
| Goup 1 | Patients extubated after general anesthesia Receives: Procedure: extubation | |
| Group 2 | Patients with complications after extubation Receives: Procedure: extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications developing during recovery-extubation
desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.
Measured: 1 hour
Secondary outcomes (2)
hemodynamic changes
heart rate
Measured: first 24 hours
hemodynamic data
mean arterial pressure
Measured: during 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 Mar 2023
- Primary completion15 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Cetinkaya, Eskisehir Osmangazi University
- Investigators
- Dilek Çetinkaya, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356649
- Sponsor's protocol ID
- ESOGU2
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel RI, Hannallah RS, Norden J, Casey WF, Verghese ST. Emergence airway complications in children: a comparison of tracheal extubation in awake and deeply anesthetized patients. Anesth Analg. 1991 Sep;73(3):266-70.
PubMed 1867418Jeong H, Tanatporn P, Ahn HJ, Yang M, Kim JA, Yeo H, Kim W. Pressure Support versus Spontaneous Ventilation during Anesthetic Emergence-Effect on Postoperative Atelectasis: A Randomized Controlled Trial. Anesthesiology. 2021 Dec 1;135(6):1004-1014. doi: 10.1097/ALN.0000000000003997.
PubMed 34610099Juang J, Cordoba M, Ciaramella A, Xiao M, Goldfarb J, Bayter JE, Macias AA. Incidence of airway complications associated with deep extubation in adults. BMC Anesthesiol. 2020 Oct 29;20(1):274. doi: 10.1186/s12871-020-01191-8.
PubMed 33121440Ata AR, Cetinkaya D, Yaman F. Investigating the effects of pressure support ventilation and positive end-expiratory pressure during extubation on respiratory system complications. Perioper Med (Lond). 2024 Dec 18;13(1):118. doi: 10.1186/s13741-024-00477-6.
PubMed 39696646
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes on Respiratory System Complications During Extubation
- ClinicalTrials.gov ID
- NCT06356649
- Acronym / sponsor ID
- ESOGU2
- Conditions
- Anesthesia
- Keywords
- pressure controlled ventilation, positive end-expiratory pressure, tracheal extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 10 Apr 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.
Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications.
Detailed description
After informed consent was obtained from the patients, monitoring was performed as we practice in routine anesthesia practice. Pressure controlled ventilation (PCV) mode and positive end-expiratory pressure (PEEP) were used as the mechanical ventilation mode after intubation. After the operation was completed, PCV mode on the mechanical ventilator was continued until the patient was extubated. Afterwards, patients were extubated if they complied with verbal commands and/or swallowed and/or coughed in response to vocal stimuli, pupils were in the midline and conjugated, BIS value was >80, breathing was regular, and TOF response was >90%. Hemodynamic and respiratory system complications were recorded during the intraoperative, recovery-extubation and postoperative periods. Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study. In the preoperative period, the patient's demographic data and hemodynamic data, and in the intraoperative period, respiratory data (tidal volume, pressure applied during inspiration, peep, etc.) and hemodynamic data were recorded. Complications recorded during recovery-extubation; desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goup 1 | – | Procedure: extubationPatients extubated after general anesthesia |
| Group 2 | – | Procedure: extubationPatients with complications after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic anesthesia with general anesthesia
Key inclusion criteria (1 listed)
- Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study
Key exclusion criteria (5 listed)
- The patient does not want to participate in the study.
- Known advanced lung disease, advanced-stage heart disease
- Switching from laparoscopic surgery to open surgery
- Surgical procedure exceeds 120 minutes
- intraoperative bleeding >500 ml
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 |
|---|---|---|
| extubationComplications after extubation | Procedure or surgery | Goup 1, Group 2 |
Primary outcome
Complications developing during recovery-extubation
Time frame: 1 hour
desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.
2 secondary outcomes
hemodynamic changes
Time frame: first 24 hours
hemodynamic data
Time frame: during 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 10 Apr 2024.
- Background: PubMed 1867418Patel RI, Hannallah RS, Norden J, Casey WF, Verghese ST. Emergence airway complications in children: a comparison of tracheal extubation in awake and deeply anesthetized patients. Anesth Analg. 1991 Sep;73(3):266-70.
- Background: PubMed 34610099Jeong H, Tanatporn P, Ahn HJ, Yang M, Kim JA, Yeo H, Kim W. Pressure Support versus Spontaneous Ventilation during Anesthetic Emergence-Effect on Postoperative Atelectasis: A Randomized Controlled Trial. Anesthesiology. 2021 Dec 1;135(6):1004-1014. doi: 10.1097/ALN.0000000000003997.
- Results publication: PubMed 33121440Juang J, Cordoba M, Ciaramella A, Xiao M, Goldfarb J, Bayter JE, Macias AA. Incidence of airway complications associated with deep extubation in adults. BMC Anesthesiol. 2020 Oct 29;20(1):274. doi: 10.1186/s12871-020-01191-8.
- Derived from this study: PubMed 39696646Ata AR, Cetinkaya D, Yaman F. Investigating the effects of pressure support ventilation and positive end-expiratory pressure during extubation on respiratory system complications. Perioper Med (Lond). 2024 Dec 18;13(1):118. doi: 10.1186/s13741-024-00477-6.
- 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.
Dilek Çetinkaya principal investigator
Eskisehir Osmangazi University
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 Anesthesia, run by Eskisehir Osmangazi 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 1 inclusion and 5 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 10 Apr 2024. 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?
Complications developing during recovery-extubation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06356649, which also lists 4 linked publications.
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 10 Apr 2024.