Nasal Mask Ventilation During the Induction of General Anesthesia

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651286
• Other study ID #: 2011P001283
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: January 15, 2017
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Mechanical Ventilation Complication
• Upper Airway Obstruction

Intervention

Procedure:
• nasal mask
Using the nasal mask instead of the full face mask during the induction of general anesthesia
• full face mask
using a standard full face mask during the induction of general anesthesia.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal volume	Tidal volume generated by the positive pressure ventilation during the induction of general anesthesia	in 30 minutes after the induction of general anesthesia
Secondary	Carbon dioxide removal	carbon dioxide removed per minute during the induction of general anesthesia will be calculated	in 30 minutes after the induction of general anesthesia
Secondary	success rate of positive pressure ventilation with different masks		in 30 minute after the induction of general anesthesia