Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02828280
Other study ID # IRB_00042299
Secondary ID
Status Completed
Phase N/A
First received June 17, 2016
Last updated May 6, 2017
Start date May 2011
Est. completion date January 2014

Study information

Verified date May 2017
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The direct objective of this study is to determine whether an experienced provider can more adequately and/or easily ventilate an anesthetized patient with the NuMask device as compared to traditional bag-valve-mask ventilation. These are approved masks, being used in the patients routine care. The researchers believe that mean tidal volumes obtained by experienced providers when manually ventilating anesthetized patients with the NuMask device will be larger than when using the traditional bag-valve-mask.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- 44 adults total

- ASA status I-III

- aged 18-64

- elective surgery at the University of Utah under general anesthesia

- Bearded, BMI >35 or edentulous

Exclusion Criteria:

- ASA IV or higher

- Oropharyngeal or facial pathology

- Risk of aspiration (defined by need for rapid sequence intubation, uncontrolled gastroesophageal reflux disease)

- Known and/or documented difficulty placing an endotracheal tube in the past

- Limited neck extension or flexion

- Personal or familial history of malignant hyperthermia

- Known or predicted severe respiratory disease or compromise

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NuMask
The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.
Traditional mask
A traditional air inflated facemark used to ventilate patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Derek Sakata

References & Publications (1)

Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Tidal Volume comparison Tidal volumes delivered between the two devices will be compared 2 minutes (one minute for NuMask, one minute for traditional mask)
Secondary Ease of use Provider will rate each device for ease of use on a 1-5 scale with 1 being easy and 5 being difficult. 2 minutes
See also
  Status Clinical Trial Phase
Completed NCT02580526 - Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia N/A
Completed NCT02627001 - Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial Phase 4
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT02103777 - High Versus Low Dose of Caffeine for Apnea of Prematurity Phase 3
Completed NCT00950287 - Detection of Neonatal Bradycardia N/A
Recruiting NCT00382876 - Identifying the Relative Change in Ventilation in Newborns With Placement in Car Bed or Car Seat N/A
Completed NCT00369759 - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants N/A
Completed NCT04084535 - Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea. N/A
Recruiting NCT02968797 - Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation
Completed NCT02554110 - Peripheral Nerve Stimulation to Reduce Hypoxic Events N/A
Not yet recruiting NCT04366414 - Breathing Protocol in Breath-hold Divers N/A
Completed NCT05124093 - The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea N/A
Recruiting NCT01994785 - Use of Capnography in EGD and Colonoscopy With Moderate Sedation. N/A
Completed NCT01435486 - Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants N/A
Completed NCT01852929 - Sleep Apnea and Visual Perceptual Skill Learning N/A
Completed NCT00389909 - Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants Phase 4
Completed NCT00188968 - Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants. Phase 3
Not yet recruiting NCT05396274 - High Flow Nasal Oxygen Therapy Undergoing Colonoscopy N/A
Completed NCT02800213 - Ventilation Using a Bag Valve Mask With Supplemental External Handle N/A
Completed NCT02375230 - MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room N/A