An Algorithmic Approach to Preoxygenation

NCT06736197 | Completed

• 1 other identifier: PamukkaleUCTanriverdi-001
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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

Conditions

Preoxygenation; Anaesthesia Induction; Non-invasive Positive Pressure Ventilation

Keywords

anaesthesia; preoxygenation; tidal volume; PSV; PEEP

Outcome Measures

Primary Outcomes (1)

• Adequate preoxygenation.

  The moment of ensuring adequate preoxygenation when the end-tidal oxygen value is 90 and above.

  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 (1)

• Adverse effects

  Within 5 min until target preoxygenation is reached.

Study Arms (3)

Group TVB

EXPERIMENTAL

Group TVB patients who could not reach 90% ETO2 at the end of the 3rd minute were continued with tidal volume breathing.

Procedure: Group TVB

Group PSV

EXPERIMENTAL

Group PSV received 6 cm H2O positive pressure ventilation.

Procedure: Group PSV

Group PSV+PEEP

EXPERIMENTAL

In addition to 6 cmH2O pressure support, 4 cmH2O end-expiratory positive pressure support was added to the patients included in Group PEEP.

Procedure: Group PSV; Procedure: Group PSV+PEEP

Interventions

Group TVB PROCEDURE

Patients who could not reach ETO2 value 90 with tidal volume breathing for 3 min were included in Group TVB tidal volume breathing was continued for 2 min.

Also known as: Tidal volume breathing was continued.

Group TVB

Group PSV PROCEDURE

Preoxygenation was continued by providing 6cmH2O pressure support to the patients included in this group.

Group PSV; Group PSV+PEEP

Group PSV+PEEP PROCEDURE

At the 4th minute, preoxygenation was continued by adding 4 cmH2O positive end-expiratory pressure to the same 6 cmH2O pressure support for 1 min in patients whose end-tidal O2 value still reached 90% and who were included in this group.

Group PSV+PEEP

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (1)

• Tanriverdi C, Yuksel Tanriverdi S, Tomatir E. Preoxygenation algorithm: sequential PSV and PEEP versus tidal volume breathing. a randomized controlled trial. Perioper Med (Lond). 2025 Oct 15;14(1):111. doi: 10.1186/s13741-025-00575-z.

  PMID: 41094613 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, Department of Anesthesiology and Reanimation, Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: December 16, 2024
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

TU (1)