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Completed

NCT Number: NCT01651286

Nasal Mask Ventilation During the Induction of General Anesthesia

Recently, the investigators demonstrated that nasal route ventilation is superior to the nasal-oral combined ventilation in the absence of jaw thrust and chin up maneuvers. The investigators hypothesize nasal mask ventilation may reduce the incidence of difficult mask ventilation during the induction of general anesthesia by: 1) producing a better seal than full face mask, and 2)establishing a greater airway patency and more effectively ventilate than full face mask ventilation. The investigators intend to test this hypothesis on adult patients during the induction of general anesthesia in the absence of muscle relaxation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years of age
  • ASA physical status classification I-II
  • general anesthesia
  • elective surgery
  • who are able to breathe through both their nose and mouth while awake

Exclusion criteria

  • Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
  • Abnormal vital signs on the day of admission for surgery [heart rate (HR, >100 bpm or <40 bpm), blood pressure (BP, >180/100 mmHg or <90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) <96%] that are not correctable with his or her routine medication or commonly used pre-operative medication.
  • Unable to open mouth (<2.5 cm) or unable to breathe through their mouth or nose.
  • Any person with an anticipated difficult airway. This will include subjects that require or may require either a fiberoptic intubation or intubation while awake.
  • Gastric-esophageal reflex or a full stomach.
  • Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or Transient Ischemic Attack (TIA) within 2 weeks.
  • Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
  • Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os - Nothing By Mouth) guidelines.

Treatment and study plan

nasal mask

Procedure

Using the nasal mask instead of the full face mask during the induction of general anesthesia

full face mask

Procedure

using a standard full face mask during the induction of general anesthesia.

Primary outcomes

  1. Tidal volume

    Time frame: in 30 minutes after the induction of general anesthesia

    Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia

Secondary outcomes

  1. Carbon dioxide removal

    Time frame: in 30 minutes after the induction of general anesthesia

    carbon dioxide removed per minute during the induction of general anesthesia will be calculated

  2. success rate of positive pressure ventilation with different masks

    Time frame: in 30 minute after the induction of general anesthesia

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Determination of the Efficacy of Nasal Mask Ventilation During the Induction of General Anesthesia

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 27, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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