Goal Directed Numeric Coaching as a Means of Preoxygenation

NCT05978635 | Completed

• 1 other identifier: 16D.091
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pre-oxygenation

Keywords

Pre-oxygenation, vital capacity breaths

Outcome Measures

Primary Outcomes (1)

• Vital capacity breaths measured in milliliters

  Measured vital capacity breaths volume in milliliters

  Pre oxygenation period prior to induction of general anesthesia

Study Arms (2)

Group A

PLACEBO COMPARATOR

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.

Group B

EXPERIMENTAL

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

Interventions

Group A Standard 4 deep breaths measured in milliliters from the ventilator. BEHAVIORAL

Tidal volume breath measured in milliliters

Group A

Group B Coached 4 deep breaths measured in milliliters from the ventilator BEHAVIORAL

Coached tidal volume breath measured in milliliters

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Osteopathic Medicine

Model Details: Once an adequate seal with consistent end tidal carbon dioxide on capnography is achieved, time starts. Patients are divided into two groups: Group A: Anesthesia provider encourages patient to breathe deeply by intermittently stating "take as deep a breath as you can". No goal directed numeric coaching is given. End point is 80% expired oxygen. The time it takes to achieve this end point and breath volumes are recorded. Group B: Anesthesia provider gives goal directed numeric coaching. For example, if the initial tidal volume achieved by the patient is 500mL, the provider states, "that was a 500mL breath, now try to achieve a 1000mL breath". The numeric goal should continue to increase above the patient's actual tidal volume (volume moved in and out of lungs during normal, quiet breathing) until an end point of 80% is reached. The time it takes to achieve this end point and breath volumes are recorded.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 7, 2023
• Study Start: March 17, 2016
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share