Descriptive Observational Study of Patient-performed Pre-oxygenation

Anxiety Clinical Trial

— ApréOx  

Official title:

"Observational Descriptive Study of Patient-performed Preoxygenation, the "Autopreoxygenation Concept""

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361693
• Other study ID #: APHP240147
• Secondary ID: 2024-A00143-44
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sophie TOUSSAINT, Nurse anesthetist
• Phone: 00 33 1 58 41 45 17
• Email: sophie.toussaint[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient). This is the concept of "self-preoxygenation".

Description:

Pre-oxygenation is a fundamental element of the induction sequence in anesthesia, described and recommended since 1955. Numerous studies have examined and compared the various techniques for implementing this procedure in terms of duration, objectives, equipment, patient characteristics and conditions. None of them specifies who should hold the mask when carrying out this recommendation. In everyday practice, patients are often asked to hold the mask themselves. A preliminary survey showed that 86% of patients are offered this option. The professionals questioned cited relational reasons (83%) above all, but also organizational reasons (43%).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing scheduled surgery with general anesthesia
• Patient classified ASA I or II
• Patient understanding and speaking French
• Patient informed of the study and not opposed to it
• Decision to have preoxygenation carried out by the patient.

Exclusion Criteria:

• Patients with grade II or III obesity (BMI>35)
• Patient with at least one respiratory comorbidity
• Smoking patient
• Pregnant patients
• Patient with an allergy to one of the mask's components
• Patient with cognitive impairment or known comprehension difficulties
• Patient under guardianship or curatorship
• Patient not affiliated to health care system

Related Conditions & MeSH terms

• Anesthesia
• Anxiety

Intervention

Other:
• Auto-preoxygenation
Management is not modified. Routine monitoring (ECG, BP, SpO2). As in care, the patient takes the mask and the respirator is started, delivering an inspired oxygen fraction of 100% (FiO2=1). Monitoring of : inspired fraction of oxygen, expired fraction of oxygenand end-tidal fraction of carbon dioxide. The ventilator also provides the respiratory rate and tidal volume carried out by the patient. The fresh gas flow is set by default and will be adjusted to 12l/min for patient comfort.After less than a minute, a normal capnia curve and the presence of an FeO2 value appear. Here, time is standardized to 1 min. In the absence of one of these elements, the caregiver always takes control of preoxygenation.Timer is started, it is T0 min. At T 3min, collection of values and decision-making : objectives achieved : end of this sequence. objectives not achieved, the caregiver takes control again for an additional 2 minutes in order to seek to achieve an FeO2>90%.
• APAIS scale
APAIS scale
• Visual analog anxiety scale (VAS-A)
Visual analog anxiety scale (VAS-A)
• Visual analog comfort scale (VAS-C)
Visual analog comfort scale (VAS-C)

Locations

Country	Name	City	State
France	Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FeO2>90%	Percentage of patients achieving a FeO2>90% in 3 min at 12L/min fresh gas flow on 100% oxygen.; To Evaluate the efficacity of the self-preoxygenation Assessing the effectiveness of auto-preoxygenation	3 minuts after the beginning of auto-preoxygenation - Day 1
Secondary	APAIS anxiety score	Percentage of patients with a total APAIS anxiety score greater than 10/20 in women, 12/20 in men on arrival in the operating room	On arrival in the operating room - Day 1
Secondary	Visual analog anxiety scale (VAS-A) score	Percentage of patients with a decrease in the visual analog anxiety scale score (VAS-A) between arrival and discharge in the Day Surgery Unit.; Assessing the effect of self-preoxygenation on preoperative anxiety	At arrival in the Day Surgery Unit - Day 1
Secondary	Visual analog anxiety scale (VAS-A) score	Percentage of patients with a decrease in the visual analog anxiety scale score (VAS-A) between arrival and discharge in the Day Surgery Unit.; Assessing the effect of self-preoxygenation on preoperative anxiety	At discharge from the Day Surgery Unit - Day 1
Secondary	Visual analog comfort scale (VAS-C) score	Percentage of patients having obtained a visual analog comfort scale (VAS-C) score greater than 5 out of 10 upon discharge from the Day Surgery Unit.; Assessing the effect of self-preoxygenation on comfort	At discharge from the Day Surgery Unit - Day 1