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Completed

NCT Number: NCT06736197

An Algorithmic Approach to Preoxygenation

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

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Key information

Conditions

Preoxygenation Anaesthesia Induction Non-invasive Positive Pressure Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Tidal volume breathing was continued.

Group PSV

Procedure

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

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.

Primary outcomes

  1. Adequate preoxygenation.

    Time frame: 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.

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

Secondary outcomes

  1. Adverse effects

    Time frame: Within 5 min until target preoxygenation is reached.

    Any adverse effects such as discomfort or gastric distension were noted.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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