ApneaNCT02580526
Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia
A study testing V-E mask ventilation for one minute and C-E mask ventilation for one minute in people with Apnea, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study compares the effectiveness of two kinds of two-handed facemask ventilation techniques (when breathing is supported with machines) at the time that general anesthesia is started. Study participants will start with one technique and then cross over to the other technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea
- What is being tested?
- V-E mask ventilation for one minute and C-E mask ventilation for one minute
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 17 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Requiring general anesthesia in the main operating rooms at Vanderbilt University Medical Center
- BMI greater than 30
Who cannot join
- Untreated ischemic heart diseases
- Respiratory disorders, including COPD and asthma,
- American Society of Anesthesiologists (ASA) physical class of 4 or greater,
- Undergoing emergency surgery,
- Requiring rapid sequence intubation for aspiration protection,
- Induction of anesthesia is not done with IV propofol,
- Requiring fiberoscopic intubation.
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the effectiveness of two kinds of two-handed facemask ventilation techniques (when breathing is supported with machines) at the time that general anesthesia is started. Study participants will start with one technique and then cross over to the other technique.
Read the detailed description
This study will compare the effectiveness of two-handed V-E mask ventilation technique with the C-E technique. The study hypothesis is based on following considerations:
- Using C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region.
- V-E approach maintains mouth open, creates larger oral cavity and allow positive pressure generated during inspiration to push forwards submandibular region.
Anesthesia care team members, residents or CRNAs familiar with bag-valve mask ventilation, will perform mask ventilation. After receiving preoperative medications, subjects will be placed on the operating table, and electrocardiogram, noninvasive blood pressure, and cutaneous oxyhemoglobin saturation monitoring will be applied. The depth of sedation will be assessed and kept by the care team with IV bolus of propofol.
The sizes of masks will be chosen by the care team and only one size will be used for both techniques. The subject's head will be placed in the neutral position on a pillow and elevate 10 cm from the operating room table, but no backward head tilt or jaw thrust will be performed. One hundred percent oxygen will be delivered throughout the study. The subject will be encouraged to hyperventilate by taking deep breaths to facilitate preoxygenation before the induction of anesthesia.
Pre-oxygenation will be carried out with maximal fresh gas flow and FiO2 1.0 until the expired O2 at or greater than 80%. Then anesthesia will be induced by an intravenous bolus injection of propofol (1-2 mg/kg) after an intravenous bolus injection of fentanyl (50-150 ug).
When the apnea occurs, the subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique (Group A) or with "V-E" technique (Group B). Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ration of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the expiratory tidal volume is greater than 15ml/kg of ideal body weight, then peak inspiratory pressure will be reduced to 15 cmH2O and 15cm H2O peak inspiratory pressure will be used through the entire the study. The study will be in two steps. Subject will start with one technique (Step 1) and then cross over (Step 2). The subjects in Group A will be first ventilated with "C-E" grip. If the subjects can be adequately ventilated, as defined by perceivable chest movement and carbon dioxide measured during exhalation in the first three breaths, ventilation will continue and complete total 10 breaths (Step 1). Then the subject will be ventilated with two-handed "V-E" grip (Step 2). In Step 1, if the subject cannot be adequately ventilated with C-E grip for even one of the first three breaths, then the subject crosses over and receives V-E grip. If the subject can be adequately ventilated with V-E for at least one of the first 3 breaths, ventilation will continue and complete total 10 breaths. The study will be completed. If the subject cannot be ventilated adequately for at least one of the first three breathes with C-E for the first breaths, nor after crossover with V-E grip, then the study will be terminated and routine care is applied including oral or nasal airway placement, intubation with LMA or tube or waking up the patient.
If subjects are randomized to start with "V-E" technique (Group B), the protocol will be identical to that in Group A except the sequence of applying the two ventilation techniques is reversed.
Upon completion of the study, narcotic and paralytic agent will be given in the usual way and the trachea will be intubated. The oxyhemoglobin saturation will be monitored throughout the study by pulse oximetry and will be maintained > 90%. The study will last about 5 minutes.
- Conditions
- Apnea
- Being tested
- V-E mask ventilation for one minute, C-E mask ventilation for one minute
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-E mask ventilation for one minuteProcedure or surgery
V-E approach maintains mouth open, creates larger oral cavity and allow positive pressure generated during inspiration to push forwards submandibular region.
When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique or with "V-E" technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique.
C-E mask ventilation for one minuteProcedure or surgery
Using C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region.
When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique or with "V-E" technique . Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique.
| Study group | Role | What they receive |
|---|---|---|
| V-E mask ventilation technique crossover C-E mask ventilation | Active comparator | Not described Receives: Procedure: V-E mask ventilation for one minute; Procedure: C-E mask ventilation for one minute |
| C-E mask ventilation technique crossover V-E mask ventilation | Active comparator | Not described Receives: Procedure: V-E mask ventilation for one minute; Procedure: C-E mask ventilation for one minute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in expired tidal volume for one minute of each technique
Measured: one minute of expired tidal volume for each mask ventilation technique
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion17 Nov 2015
- Study completion17 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yandong Jiang, Vanderbilt University Medical Center
- Investigators
- Yandong Jiang, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580526
- Sponsor's protocol ID
- 150903
- Status last verified
- Jul 2017
- First submitted
- 16 Oct 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cheney FW, Posner KL, Lee LA, Caplan RA, Domino KB. Trends in anesthesia-related death and brain damage: A closed claims analysis. Anesthesiology. 2006 Dec;105(6):1081-6. doi: 10.1097/00000542-200612000-00007.
PubMed 17122570Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
PubMed 10781266Ramachandran SK, Kheterpal S. Difficult mask ventilation: does it matter? Anaesthesia. 2011 Dec;66 Suppl 2:40-4. doi: 10.1111/j.1365-2044.2011.06933.x.
PubMed 22074078Wong E, Ng YY. The difficult airway in the emergency department. Int J Emerg Med. 2008 Jun;1(2):107-11. doi: 10.1007/s12245-008-0030-6. Epub 2008 May 29.
PubMed 19384660Orebaugh SL. Difficult airway management in the emergency department. J Emerg Med. 2002 Jan;22(1):31-48. doi: 10.1016/s0736-4679(01)00435-8.
PubMed 11809554Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
PubMed 18337600Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. NCHS Data Brief. 2012 Jan;(82):1-8.
PubMed 22617494Gerstein NS, Carey MC, Braude DA, Tawil I, Petersen TR, Deriy L, Anderson MS. Efficacy of facemask ventilation techniques in novice providers. J Clin Anesth. 2013 May;25(3):193-7. doi: 10.1016/j.jclinane.2012.10.009. Epub 2013 Mar 21.
PubMed 23523573Fei M, Blair JL, Rice MJ, Edwards DA, Liang Y, Pilla MA, Shotwell MS, Jiang Y. Comparison of effectiveness of two commonly used two-handed mask ventilation techniques on unconscious apnoeic obese adults. Br J Anaesth. 2017 Apr 1;118(4):618-624. doi: 10.1093/bja/aex035.
PubMed 28403406
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia
- ClinicalTrials.gov ID
- NCT02580526
- Acronym / sponsor ID
- 150903
- Conditions
- Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 17 Nov 2015 (actual)
- Study completion
- 17 Nov 2015 (actual)
- First posted
- 20 Oct 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.
This study compares the effectiveness of two kinds of two-handed facemask ventilation techniques (when breathing is supported with machines) at the time that general anesthesia is started. Study participants will start with one technique and then cross over to the other technique.
Detailed description
This study will compare the effectiveness of two-handed V-E mask ventilation technique with the C-E technique. The study hypothesis is based on following considerations:
- Using C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region.
- V-E approach maintains mouth open, creates larger oral cavity and allow positive pressure generated during inspiration to push forwards submandibular region.
Anesthesia care team members, residents or CRNAs familiar with bag-valve mask ventilation, will perform mask ventilation. After receiving preoperative medications, subjects will be placed on the operating table, and electrocardiogram, noninvasive blood pressure, and cutaneous oxyhemoglobin saturation monitoring will be applied. The depth of sedation will be assessed and kept by the care team with IV bolus of propofol.
The sizes of masks will be chosen by the care team and only one size will be used for both techniques. The subject's head will be placed in the neutral position on a pillow and elevate 10 cm from the operating room table, but no backward head tilt or jaw thrust will be performed. One hundred percent oxygen will be delivered throughout the study. The subject will be encouraged to hyperventilate by taking deep breaths to facilitate preoxygenation before the induction of anesthesia.
Pre-oxygenation will be carried out with maximal fresh gas flow and FiO2 1.0 until the expired O2 at or greater than 80%. Then anesthesia will be induced by an intravenous bolus injection of propofol (1-2 mg/kg) after an intravenous bolus injection of fentanyl (50-150 ug).
When the apnea occurs, the subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique (Group A) or with "V-E" technique (Group B). Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute, I:E ration of 1:2, peak inspiratory pressure of 20cmH2O and no PEEP. If the expiratory tidal volume is greater than 15ml/kg of ideal body weight, then peak inspiratory pressure will be reduced to 15 cmH2O and 15cm H2O peak inspiratory pressure will be used through the entire the study. The study will be in two steps. Subject will start with one technique (Step 1) and then cross over (Step 2). The subjects in Group A will be first ventilated with "C-E" grip. If the subjects can be adequately ventilated, as defined by perceivable chest movement and carbon dioxide measured during exhalation in the first three breaths, ventilation will continue and complete total 10 breaths (Step 1). Then the subject will be ventilated with two-handed "V-E" grip (Step 2). In Step 1, if the subject cannot be adequately ventilated with C-E grip for even one of the first three breaths, then the subject crosses over and receives V-E grip. If the subject can be adequately ventilated with V-E for at least one of the first 3 breaths, ventilation will continue and complete total 10 breaths. The study will be completed. If the subject cannot be ventilated adequately for at least one of the first three breathes with C-E for the first breaths, nor after crossover with V-E grip, then the study will be terminated and routine care is applied including oral or nasal airway placement, intubation with LMA or tube or waking up the patient.
If subjects are randomized to start with "V-E" technique (Group B), the protocol will be identical to that in Group A except the sequence of applying the two ventilation techniques is reversed.
Upon completion of the study, narcotic and paralytic agent will be given in the usual way and the trachea will be intubated. The oxyhemoglobin saturation will be monitored throughout the study by pulse oximetry and will be maintained > 90%. The study will last about 5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V-E mask ventilation technique crossover C-E mask ventilation | Active comparator | Procedure: V-E mask ventilation for one minute, Procedure: C-E mask ventilation for one minute |
| C-E mask ventilation technique crossover V-E mask ventilation | Active comparator | Procedure: V-E mask ventilation for one minute, Procedure: C-E mask ventilation for one minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- Requiring general anesthesia in the main operating rooms at Vanderbilt University Medical Center
- BMI greater than 30
Key exclusion criteria (7 listed)
- Untreated ischemic heart diseases
- Respiratory disorders, including COPD and asthma,
- American Society of Anesthesiologists (ASA) physical class of 4 or greater,
- Undergoing emergency surgery,
- Requiring rapid sequence intubation for aspiration protection,
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 |
|---|---|---|
| V-E mask ventilation for one minuteV-E approach maintains mouth open, creates larger oral cavity and allow positive pressure generated during inspiration to push forwards submandibular region. When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique or with "V-E" technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique. | Procedure or surgery | C-E mask ventilation technique crossover V-E mask ventilation, V-E mask ventilation technique crossover C-E mask ventilation |
| C-E mask ventilation for one minuteUsing C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region. When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed "C-E" facemask ventilation technique or with "V-E" technique . Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique. | Procedure or surgery | C-E mask ventilation technique crossover V-E mask ventilation, V-E mask ventilation technique crossover C-E mask ventilation |
Primary outcome
Difference in expired tidal volume for one minute of each technique
Time frame: one minute of expired tidal volume for each mask ventilation technique
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 11 Jul 2017.
- Background: PubMed 17122570Cheney FW, Posner KL, Lee LA, Caplan RA, Domino KB. Trends in anesthesia-related death and brain damage: A closed claims analysis. Anesthesiology. 2006 Dec;105(6):1081-6. doi: 10.1097/00000542-200612000-00007.
- Background: PubMed 10781266Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
- Background: PubMed 22074078Ramachandran SK, Kheterpal S. Difficult mask ventilation: does it matter? Anaesthesia. 2011 Dec;66 Suppl 2:40-4. doi: 10.1111/j.1365-2044.2011.06933.x.
- Background: PubMed 19384660Wong E, Ng YY. The difficult airway in the emergency department. Int J Emerg Med. 2008 Jun;1(2):107-11. doi: 10.1007/s12245-008-0030-6. Epub 2008 May 29.
- Background: PubMed 11809554Orebaugh SL. Difficult airway management in the emergency department. J Emerg Med. 2002 Jan;22(1):31-48. doi: 10.1016/s0736-4679(01)00435-8.
- Background: PubMed 18337600Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361.
- Background: PubMed 22617494Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. NCHS Data Brief. 2012 Jan;(82):1-8.
- Background: PubMed 23523573Gerstein NS, Carey MC, Braude DA, Tawil I, Petersen TR, Deriy L, Anderson MS. Efficacy of facemask ventilation techniques in novice providers. J Clin Anesth. 2013 May;25(3):193-7. doi: 10.1016/j.jclinane.2012.10.009. Epub 2013 Mar 21.
- Derived from this study: PubMed 28403406Fei M, Blair JL, Rice MJ, Edwards DA, Liang Y, Pilla MA, Shotwell MS, Jiang Y. Comparison of effectiveness of two commonly used two-handed mask ventilation techniques on unconscious apnoeic obese adults. Br J Anaesth. 2017 Apr 1;118(4):618-624. doi: 10.1093/bja/aex035.
- Individual participant dataSharing planned: No
Related trials for Apnea
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
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.
Yandong Jiang, MD, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-E mask ventilation for one minute and C-E mask ventilation for one minute in people with Apnea, run by Vanderbilt University Medical Center at 1 site in United States.
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 11 Jul 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 United States. 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?
Difference in expired tidal volume for one minute of each technique (time frame: one minute of expired tidal volume for each mask ventilation technique). 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 NCT02580526, which also lists 9 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 11 Jul 2017.