General AnesthesiaNCT02400931
The Necessity of Routine Mask Ventilation in Adults
A study testing mask ventilation, no mask ventilation and Rocuronium in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The mask ventilation is a necessary procedure to provide oxygenation before the tracheal intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex, which is recently introduced, enables the use of high-dose muscle relaxant without concerning the delayed recovery of neuromuscular… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- mask ventilation, no mask ventilation and Rocuronium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Apr 2015to 23 Nov 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients of age over 20 years for scheduled surgery with more than one and a half hours under general anesthesia
Who cannot join
- anticipated difficult mask ventilation,
- anticipated difficult intubation,
- ASA class 3 or 4,
- preoperative saturation less than 92%.,
- saturation less than 98% after preoxygenation
- body mass index over 35 kg/m2,
Show all 9Show fewer
- obstructive sleep apnea,
- mass in the oral cavity or in the trachea,
- pregnant woman
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
The mask ventilation is a necessary procedure to provide oxygenation before the tracheal intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex, which is recently introduced, enables the use of high-dose muscle relaxant without concerning the delayed recovery of neuromuscular blockade. It seems that there is no need to perform the mask ventilation in adults with normal airway if the investigators use high-dose muscle relaxant for the anesthetic induction because adequate muscle relaxation can be achieved within 1-2 minutes. Therefore, the investigators hypothesized that routine mask ventilation is not needed in adult patients with normal airway. The investigators will compare the incidence of desaturation and gastric insufflation between the patients with mask ventilation and the patients without mask ventilation.
- Conditions
- General Anesthesia
- Being tested
- mask ventilation, no mask ventilation, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mask ventilationProcedure or surgery
In mask ventilation group, rocuronium of 0.6 mg/kg will be administered after the loss of consciousness. Mask ventilation wil be performed until there is no response on the train-of-four stimulus. No mask ventilation - In no mask ventilation group, rocuronium of 1.2 mg/kg will be administered after the loss of consciousness. Tracheal intubation will be performed after confirmation of no response on the train-of-four stimulus. The mask ventilation will not be performed before the tracheal intubation.
no mask ventilationProcedure or surgery
RocuroniumDrug
| Study group | Role | What they receive |
|---|---|---|
| mask ventilation | Active comparator | Mask ventilation will be performed before the tracheal intubation. Receives: Procedure: mask ventilation; Drug: Rocuronium |
| no mask ventilation | Experimental | Mask ventilation will not be performed before the tracheal intubation. Receives: Procedure: no mask ventilation; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation (saturation less than 95%)
Primary outcome is the incidence of desaturation. Desaturation is defined as the saturation less than 95% which occurs after the anesthetic induction and before the first attempt of tracheal intubation.
Measured: until 2 minutes after the completion of tracheal intubation
Secondary outcomes (1)
gastric insufflation (observe the antral area of the stomach using ultrasonography)
Secondary outcome is the antral area of the stomach. We will observe the antral area of the stomach using ultrasonography.
Measured: until 2 minutes after the completion of tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start28 Apr 2015
- Primary completion23 Nov 2015
- Study completion23 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400931
- Sponsor's protocol ID
- 4-2015-0036
- Status last verified
- Jan 2017
- First submitted
- 23 Mar 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chang HW, Kim N, Eum D, Kim HD, Cho JG, Kim HJ. Omitting face-mask ventilation before tracheal intubation in low-risk adults: a randomized non-inferiority trial. BMC Anesthesiol. 2026 Sep 19;26(1):600. doi: 10.1186/s12871-026-04276-y.
PubMed 42844587
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Necessity of Routine Mask Ventilation in Adults
- ClinicalTrials.gov ID
- NCT02400931
- Acronym / sponsor ID
- 4-2015-0036
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 23 Nov 2015 (actual)
- Study completion
- 23 Nov 2015 (actual)
- First posted
- 27 Mar 2015 (estimated)
- 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.
The mask ventilation is a necessary procedure to provide oxygenation before the tracheal intubation although the gastric insufflation occurs during the mask ventilation. Sugammadex, which is recently introduced, enables the use of high-dose muscle relaxant without concerning the delayed recovery of neuromuscular blockade. It seems that there is no need to perform the mask ventilation in adults with normal airway if the investigators use high-dose muscle relaxant for the anesthetic induction because adequate muscle relaxation can be achieved within 1-2 minutes. Therefore, the investigators hypothesized that routine mask ventilation is not needed in adult patients with normal airway. The investigators will compare the incidence of desaturation and gastric insufflation between the patients with mask ventilation and the patients without mask ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mask ventilation | Active comparator | Procedure: mask ventilation, Drug: RocuroniumMask ventilation will be performed before the tracheal intubation. |
| no mask ventilation | Experimental | Procedure: no mask ventilation, Drug: RocuroniumMask ventilation will not be performed before the tracheal intubation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients of age over 20 years for scheduled surgery with more than one and a half hours under general anesthesia
Key exclusion criteria (9 listed)
- anticipated difficult mask ventilation,
- anticipated difficult intubation,
- ASA class 3 or 4,
- preoperative saturation less than 92%.,
- saturation less than 98% after preoxygenation
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 |
|---|---|---|
| mask ventilationIn mask ventilation group, rocuronium of 0.6 mg/kg will be administered after the loss of consciousness. Mask ventilation wil be performed until there is no response on the train-of-four stimulus. No mask ventilation - In no mask ventilation group, rocuronium of 1.2 mg/kg will be administered after the loss of consciousness. Tracheal intubation will be performed after confirmation of no response on the train-of-four stimulus. The mask ventilation will not be performed before the tracheal intubation. | Procedure or surgery | mask ventilation |
| no mask ventilation | Procedure or surgery | no mask ventilation |
| Rocuronium | Drug | mask ventilation, no mask ventilation |
Primary outcome
Desaturation (saturation less than 95%)
Time frame: until 2 minutes after the completion of tracheal intubation
Primary outcome is the incidence of desaturation. Desaturation is defined as the saturation less than 95% which occurs after the anesthetic induction and before the first attempt of tracheal intubation.
1 secondary outcome
gastric insufflation (observe the antral area of the stomach using ultrasonography)
Time frame: until 2 minutes after the completion of tracheal intubation
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 25 Jan 2017.
- Derived from this study: PubMed 42844587Chang HW, Kim N, Eum D, Kim HD, Cho JG, Kim HJ. Omitting face-mask ventilation before tracheal intubation in low-risk adults: a randomized non-inferiority trial. BMC Anesthesiol. 2026 Sep 19;26(1):600. doi: 10.1186/s12871-026-04276-y.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mask ventilation, no mask ventilation and Rocuronium in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
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 9 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 25 Jan 2017. 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 South Korea. 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?
Desaturation (saturation less than 95%) (time frame: until 2 minutes after the completion of tracheal intubation). 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 NCT02400931, which also lists 1 linked publication.
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 25 Jan 2017.