Goal Directed Numeric Coaching as a Means of Preoxygenation

Pre-oxygenation is an anesthetic technique that allows for extended apneic (suspension of breathing) time prior to attempted endotracheal intubation. A common method to achieve adequate pre-oxygenation is having a patient take four vital capacity breaths of 100% oxygen in thirty seconds. This study seeks to determine if goal directed numeric coaching can lead to more accurate vital capacities during this technique.

Study Overview

• Status: Completed
• Conditions: Pre-oxygenation
• Intervention / Treatment: Behavioral: Group A Standard 4 deep breaths measured in milliliters from the ventilator.; Behavioral: Group B Coached 4 deep breaths measured in milliliters from the ventilator

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists Physical Status 1 and 2
• nonsmokers
• primary English speaking
• undergoing elective surgery with planned endotracheal intubation

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; Anesthesia provider asks the patient to take 4 deep breaths by intermittently stating "take as deep a breath as you can". This is the standard of care technique for preoxygenation before induction of general anesthesia with the end point being 80% expired oxygen. The breath volumes in milliliters are recorded but not stated to the patient.	Behavioral: Group A Standard 4 deep breaths measured in milliliters from the ventilator.; Tidal volume breath measured in milliliters
Experimental: Group B; Anesthesia provider asks the patient to take 4 deep breaths but provides coaching by informing the patient of the numeric volume (milliliters) to reach for every breath. Each tidal volume breath is measured using the anesthesia ventilator and the provider encourages the patient to achieve a higher tidal volume than previously achieved. For example, if the initial tidal volume achieved by the patient is 500 milliliter, the provider states, "that was a 500 milliliter breath, now try to achieve a 1000mL breath". The numeric goal should continue to increase above the patient's actual tidal volume. The breath volumes are recorded.	Behavioral: Group B Coached 4 deep breaths measured in milliliters from the ventilator; Coached tidal volume breath measured in milliliters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital capacity breaths measured in milliliters	Measured vital capacity breaths volume in milliliters	Pre oxygenation period prior to induction of general anesthesia

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2016
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pre-oxygenation, vital capacity breaths
• Other Study ID Numbers: 16D.091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No