Nasal Mask Ventilation During the Induction of General Anesthesia

NCT ID: NCT01651286

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-08-31

Brief 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.

Conditions

Mechanical Ventilation Complication; Upper Airway Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

nasal mask

when the patient is apneic after the injection of anesthetics in the operating room, a nasal mask will be applied with positive pressure ventilation for 1 min. Then the nasal mask will be replaced with a full face mask for 1 min. Subsequently, the face mask will be replaced with the nasal mask.

Group Type: EXPERIMENTAL

nasal mask

Intervention Type: PROCEDURE

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

full face mask

Intervention Type: PROCEDURE

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

full face mask

when the patient is apneic after the injection of anesthetics in the operating room, a full face mask will be applied with positive pressure ventilation for 1 min. Then the full face mask will be replaced with a nasal mask for 1 min. Subsequently, the nasal mask will be replaced with the full face mask.

Group Type: ACTIVE_COMPARATOR

nasal mask

Intervention Type: PROCEDURE

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

full face mask

Intervention Type: PROCEDURE

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

Interventions

nasal mask

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

Intervention Type: PROCEDURE

full face mask

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yandong Jiang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hovig V Chitilian, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Yandong Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011P001283

Identifier Type: -

Identifier Source: org_study_id