Obesity, MorbidNCT06219460
Comparison of Two Types of Face Mask Ventilation in Obese Patients
A study testing Ventilation using two types of face masks in people with Obesity, Morbid, run by Medical University of Lodz at 1 site in Poland.
Trial summary
Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Ventilation using two types of face masks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 1 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obesity
- scheduled for elective surgery under general anesthesia
Who cannot join
- predicted difficult intubation
- predicted difficult face-mask ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Types of Face Masks: Cuffed and Uncuffed for Ventilation of Obese Patients
Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. The inspired and expired volume was measured using anesthesia machine volumeter, The difference between inspired and expired volume was counted. The comparison between two types of masks was performed taking into consideration several parameters: type of obesity, gender, age.
Read the detailed description
The aim of the study was to determine which of the tested: cuffed or uncuffed face masks allows better replacement ventilation in obese patients.
The study was conducted on patients with the BMI over 39 kg/m2 Patients qualified for bariatric surgery were selected for this study according to the order of reporting to the surgery department. The study adopted a simplified assumption that the gynoid type of obesity most often concerns women, and the android type, i.e. abdominal obesity, most often affects men. Two face masks were used to compare the effectiveness of replacement ventilation: the cuffed and uncuffed . It was randomly chosen (by tossing a coin) which face mask would be used first. The induction of anesthesia was low-opioid, the patients were placed in the supine position with the head and trunk elevated by 25 degrees on a positioning pad. 100% oxygen concentration was used for active pre-oxygenation, the test mask was applied with one hand using the EC clamp technique. The masks were changed after four consecutive measurements for each type of mask. In order to objectify the measurement with the same tidal volume, a respirator was used with the same settings: Tidal Volume of 500 ml and respiratory rate of 12/min. Sealing was measured by comparing the inspired volume with expired volume, that is the amount of leakage generated by individual masks was assessed. The obtained data were analyzed with the Kolmogorow-Smirnov test and supplemented with the values of the Wilcoxona test.
- Conditions
- Obesity, Morbid
- Being tested
- Ventilation using two types of face masks
- Keywords
- morbid obesity, face mask ventilation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation using two types of face masksOther
ventilation using two types of face mask
| Study group | Role | What they receive |
|---|---|---|
| Cuffed face amsk | Experimental | Ventilation using cuffed face mask Receives: Other: Ventilation using two types of face masks |
| Uncuffed face mask | Experimental | Ventilation using uncuffed face mask Receives: Other: Ventilation using two types of face masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealing of face masks measured by difference of inspired tidal volume and expired volume
Sealing of cuffed or uncuffed masks during face mask ventilation in obese patients measred by anesthesia machine
Measured: immediatethrough study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Gaszynski, Medical University of Lodz
- Investigators
- Tomasz Gaszynski, Prof, Principal investigator, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219460
- Sponsor's protocol ID
- RNN/96/13/KB
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Types of Face Masks: Cuffed and Uncuffed for Ventilation of Obese Patients
- ClinicalTrials.gov ID
- NCT06219460
- Acronym / sponsor ID
- RNN/96/13/KB
- Conditions
- Obesity, Morbid
- Keywords
- morbid obesity, face mask ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Jan 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.
Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. The inspired and expired volume was measured using anesthesia machine volumeter, The difference between inspired and expired volume was counted. The comparison between two types of masks was performed taking into consideration several parameters: type of obesity, gender, age.
Detailed description
The aim of the study was to determine which of the tested: cuffed or uncuffed face masks allows better replacement ventilation in obese patients.
The study was conducted on patients with the BMI over 39 kg/m2 Patients qualified for bariatric surgery were selected for this study according to the order of reporting to the surgery department. The study adopted a simplified assumption that the gynoid type of obesity most often concerns women, and the android type, i.e. abdominal obesity, most often affects men. Two face masks were used to compare the effectiveness of replacement ventilation: the cuffed and uncuffed . It was randomly chosen (by tossing a coin) which face mask would be used first. The induction of anesthesia was low-opioid, the patients were placed in the supine position with the head and trunk elevated by 25 degrees on a positioning pad. 100% oxygen concentration was used for active pre-oxygenation, the test mask was applied with one hand using the EC clamp technique. The masks were changed after four consecutive measurements for each type of mask. In order to objectify the measurement with the same tidal volume, a respirator was used with the same settings: Tidal Volume of 500 ml and respiratory rate of 12/min. Sealing was measured by comparing the inspired volume with expired volume, that is the amount of leakage generated by individual masks was assessed. The obtained data were analyzed with the Kolmogorow-Smirnov test and supplemented with the values of the Wilcoxona test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuffed face amsk | Experimental | Other: Ventilation using two types of face masksVentilation using cuffed face mask |
| Uncuffed face mask | Experimental | Other: Ventilation using two types of face masksVentilation using uncuffed face mask |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- obesity
- scheduled for elective surgery under general anesthesia
Key exclusion criteria (2 listed)
- predicted difficult intubation
- predicted difficult face-mask ventilation
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 |
|---|---|---|
| Ventilation using two types of face masksventilation using two types of face mask | Other | Cuffed face amsk, Uncuffed face mask |
Primary outcome
Sealing of face masks measured by difference of inspired tidal volume and expired volume
Time frame: immediatethrough study completion
Sealing of cuffed or uncuffed masks during face mask ventilation in obese patients measred by anesthesia machine
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 23 Jan 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.
Tomasz Gaszynski, Prof principal investigator
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation using two types of face masks in people with Obesity, Morbid, run by Medical University of Lodz at 1 site in Poland.
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 2 inclusion and 2 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 23 Jan 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 Poland. 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?
Sealing of face masks measured by difference of inspired tidal volume and expired volume (time frame: immediatethrough study completion). 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 23 Jan 2024.