AnesthesiaNCT04617665
Effects of One-handed and Two-handed Mask Ventilation Techniques on Global and Regional Lung Ventilation
A study testing One-handed mask ventilation and Two-handed mask ventilation in people with Anesthesia, run by Fudan University.
Trial summary
Two-handed mask ventilation has been shown to provide higher tidal volume than one-handed mask ventilation. The effects of the two techniques on respiratory mechanics during induction of general anesthesia, however, still need to be determined. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- One-handed mask ventilation and Two-handed mask ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2020
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for elective surgery with general anesthesia
- American Society of Anesthesiologist (ASA) physical class of I-II.
Who cannot join
- acute and chronic respiratory disorders, including chronic obstructive
- pulmonary disease (COPD) and asthma;
- a history of lung surgery;
- exist risk of reflux and aspiration;
- patients requiring an awake intubation;
- facial and thoracic deformities;
- implants exist in the body, such as cardiac pacemakers;
- pregnant women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Department of Anesthesiology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China.
Two-handed mask ventilation has been shown to provide higher tidal volume than one-handed mask ventilation. The effects of the two techniques on respiratory mechanics during induction of general anesthesia, however, still need to be determined.
Read the detailed description
Mask positive pressure ventilation always causes the changes of respiratory mechanics such as ventral redistribution of regional ventilation, which impairs gas exchange. Two-handed mask ventilation has been shown to improve gas exchange by providing higher tidal volume than one-handed mask ventilation. We hypothesis that those higher tidal volume caused by two-handed mask ventilation would also improve the respiratory mechanics during induction of general anesthesia.
- Conditions
- Anesthesia
- Being tested
- One-handed mask ventilation, Two-handed mask ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-handed mask ventilationOther
Using one-handed mask ventilation techniques during induction of general anesthesia
Two-handed mask ventilationOther
Using two-handed mask ventilation techniques during induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| One-handed mask ventilation | Other | For the one-handed mask ventilation, only one hand can be used to achieve the face mask seal. The left thumb and index finger form a ''C,'' providing anterior pressure over the mask, while the third, fourth, and fifth fingers form an ''E'' to lift the jaw. Receives: Other: One-handed mask ventilation |
| Two-handed mask ventilation | Other | For the two-handed mask ventilation, the provider's thumb and thenar eminence of each hand are held parallel, adjacent to the mask connector, and depress each side of the mask. The second through fifth digits wrap around and elevate the mandible to draw it anteriorly into the mask establishing both a jaw-thrust and chin-lift maneuver when appropriate. Receives: Other: Two-handed mask ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
global inhomogeneity (GI)
EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data. 0% = homogenous
Measured: 8 weeks
Secondary outcomes (5)
centre of ventilation (CoV)
EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data. 100% = entirely dorsal.
Measured: 8 weeks
regional ventilation delay (RVD)
EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data.
Measured: 8 weeks
ventilation of regional lung ( %)
EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data.
Measured: 8 weeks
Expiratory tidal volume (TV)
Expiratory tidal volume will be recorded through the anesthesia machine.
Measured: 8 weeks
PaO2/FiO2
PaO2/FiO2 will be recorded through arterial blood gas analysis.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Zhang, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617665
- Sponsor's protocol ID
- Mask ventilation
- Status last verified
- Oct 2020
- First submitted
- 25 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data or documents can be obtained by contact the corresponding authors. Files can be emailed to anyone that concerned.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology, Fudan University Shanghai Cancer Center, Fudan University, Shanghai, China.
- ClinicalTrials.gov ID
- NCT04617665
- Acronym / sponsor ID
- Mask ventilation
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Nov 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.
Two-handed mask ventilation has been shown to provide higher tidal volume than one-handed mask ventilation. The effects of the two techniques on respiratory mechanics during induction of general anesthesia, however, still need to be determined.
Detailed description
Mask positive pressure ventilation always causes the changes of respiratory mechanics such as ventral redistribution of regional ventilation, which impairs gas exchange. Two-handed mask ventilation has been shown to improve gas exchange by providing higher tidal volume than one-handed mask ventilation. We hypothesis that those higher tidal volume caused by two-handed mask ventilation would also improve the respiratory mechanics during induction of general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-handed mask ventilation | Other | Other: One-handed mask ventilationFor the one-handed mask ventilation, only one hand can be used to achieve the face mask seal. The left thumb and index finger form a ''C,'' providing anterior pressure over the mask, while the third, fourth, and fifth fingers form an ''E'' to lift the jaw. |
| Two-handed mask ventilation | Other | Other: Two-handed mask ventilationFor the two-handed mask ventilation, the provider's thumb and thenar eminence of each hand are held parallel, adjacent to the mask connector, and depress each side of the mask. The second through fifth digits wrap around and elevate the mandible to draw it anteriorly into the mask establishing both a jaw-thrust and chin-lift maneuver when appropriate. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for elective surgery with general anesthesia
- American Society of Anesthesiologist (ASA) physical class of I-II.
Key exclusion criteria (8 listed)
- acute and chronic respiratory disorders, including chronic obstructive
- pulmonary disease (COPD) and asthma;
- a history of lung surgery;
- exist risk of reflux and aspiration;
- patients requiring an awake intubation;
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 |
|---|---|---|
| One-handed mask ventilationUsing one-handed mask ventilation techniques during induction of general anesthesia | Other | One-handed mask ventilation |
| Two-handed mask ventilationUsing two-handed mask ventilation techniques during induction of general anesthesia | Other | Two-handed mask ventilation |
Primary outcome
global inhomogeneity (GI)
Time frame: 8 weeks
EIT images will be acquired by using the EIT monitor (Drager Medical Gmbh, Lubeck, Germany). And a software package (Electrical impedance tomography diag custom software provided by Drager Medical) will be used to quantitatively analyze the EIT data. 0% = homogenous
5 secondary outcomes
centre of ventilation (CoV)
Time frame: 8 weeks
regional ventilation delay (RVD)
Time frame: 8 weeks
ventilation of regional lung ( %)
Time frame: 8 weeks
Expiratory tidal volume (TV)
Time frame: 8 weeks
PaO2/FiO2
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Yes. Data or documents can be obtained by contact the corresponding authors. Files can be emailed to anyone that concerned.
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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.
Jun Zhang, PhD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing One-handed mask ventilation and Two-handed mask ventilation in people with Anesthesia, run by Fudan University.
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 8 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: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang, PhD (13817153025, snapzhang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global inhomogeneity (GI) (time frame: 8 weeks). 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 5 Nov 2020.