Trial Outcomes & Findings for Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy (NCT NCT03139448)

Results Overview

The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

174 participants

Primary outcome timeframe

Usually 5 minutes

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Oxygen Via Nasal Cannula (Standard of Care) The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	Oxygen Via SuperNO2VA Nasal Mask The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Overall Study STARTED	85	89
Overall Study Intervention Started	79	70
Overall Study COMPLETED	73	63
Overall Study NOT COMPLETED	12	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxygen Via Nasal Cannula (Standard of Care) The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	Oxygen Via SuperNO2VA Nasal Mask The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Overall Study Lack of Efficacy	6	7
Overall Study Location of procedure changed	2	8
Overall Study Withdrawal by Subject	3	6
Overall Study Screen fail	1	3
Overall Study Physician Decision	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxygen Via Nasal Cannula (Standard of Care) n=73 Participants The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	Oxygen Via SuperNO2VA Nasal Mask n=63 Participants The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=73 Participants	0 Participants n=63 Participants	0 Participants n=136 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=73 Participants	50 Participants n=63 Participants	111 Participants n=136 Participants
Age, Categorical >=65 years	12 Participants n=73 Participants	13 Participants n=63 Participants	25 Participants n=136 Participants
Sex: Female, Male Female	47 Participants n=73 Participants	33 Participants n=63 Participants	80 Participants n=136 Participants
Sex: Female, Male Male	26 Participants n=73 Participants	30 Participants n=63 Participants	56 Participants n=136 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	73 Participants n=73 Participants	63 Participants n=63 Participants	136 Participants n=136 Participants

PRIMARY outcome

Timeframe: Usually 5 minutes

The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.