Clinical trial NCT06736197: An Algorithmic Approach to Preoxygenation
Official title: An Algorithmic Approach to Preoxygenation: Stepwise Addition of Pressure Support and Positive End-expiratory Pressure When Tidal Volume Breathing is Inadequate. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoxygenation
Anaesthesia Induction
Non-invasive Positive Pressure Ventilation
Keywords: anaesthesia
preoxygenation
tidal volume
PSV
PEEP
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study was performed in 200 patients planned for general anaesthesia for elective surgery, aged 18-65 years, ASA 1-2 physical status, without premedication and ETO2 \<90% at the end of the 3rd minute with spontaneous TVB of 100% oxygen. The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).
Primary purpose: PREVENTION

Brief summary: The aim of this randomized controlled trial is to evaluate an algorithmic approach to gradually adding pressure-supported ventilation and end-tidal positive pressure when conventional tidal volume breathing is insufficient for adequate preoxygenation. The main question it aims to answer is:

* Will the proportion of patients receiving preoxygenation increase?
* Will the duration of preoxygenation decrease?

Participants will;

* 200 patients who were planned to undergo general anesthesia for elective surgeries
* aged between 18 and 65 years
* ASA 1-2 physical status
* ETO2 \<90% at the end of the 3rd minute with spontaneous tidal volume breathing

Detailed description: The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).

When adequate preoxygenation was achieved, the duration of preoxygenation, SpO2, end-tidal carbon dioxide (ETCO2), arterial blood pressures and heart rate values were recorded. Any adverse effects such as discomfort or gastric distension were noted.

Eligibility criteria: Inclusion Criteria:

* Elective surgeries general anaesthesia was planned for a patient aged 18-65 years with ASA 1-2 physical condition.

Exclusion Criteria:

* Haemodynamically unstable, preoperative oxygen support such as increased intracranial or intraocular pressure, to be operated on by thoracic surgery have conditions in which positive pressure ventilation may be indirectly harmful, BMI≥35 kg/m2, pregnant, undergoing emergency surgery and causing leakage in mask ventilation bearded male patients were not included in the study.

Primary outcomes:
measure: Adequate preoxygenation.
timeFrame: The moment when the end-tidal oxygen value of patients with insufficient preoxygenation at the end of the third minute with spontaneous tidal volume breathing is 90 and above.
Secondary outcomes:
measure: Adverse effects
timeFrame: Within 5 min until target preoxygenation is reached.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: