Quality of Preoxygenation in Emergency Surgery

Surgery Clinical Trial

Official title:

Study of Preoxygenation Quality Prior to General Anesthesia in Emergency Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070404
• Other study ID #: 19BMT30
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: October 2020
• Source: Vilnius University
• Contact: Egle Kontrimaviciute, Assoc Professor
• Phone: +37052365264
• Email: egle.kontrimaviciute[@]santa.lt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.

The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.

Description:

Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.

Parameters analysed:

• Preoperative: medical history, physical examination, laboratory findings, anthropometric data

• Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• written informed consent

• patient going for emergency surgery under general anaesthesia

• age > 18 years

Exclusion Criteria:

• informed consent refusal

• noneligible for preoxygenation before general anaesthesia

Related Conditions & MeSH terms

• Anaesthesia
• Emergencies
• Preoxygenation
• Surgery

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros Clinics	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficient preoxygenation in preset time	End-tidal oxygen concentration values	300 seconds
Secondary	Factors influencing preoxygenation quality	Medical history, physical status, lab findings, preoxygenation equipment and method	300 seconds