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An Algorithmic Approach to Preoxygenation

NCT ID: NCT06736197

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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Preoxygenation Anaesthesia Induction Non-invasive Positive Pressure Ventilation

Keywords

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anaesthesia preoxygenation tidal volume PSV PEEP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group TVB

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

Group Type EXPERIMENTAL

Group TVB

Intervention Type 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.

Group PSV

Group PSV received 6 cm H2O positive pressure ventilation.

Group Type EXPERIMENTAL

Group PSV

Intervention Type PROCEDURE

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

Group PSV+PEEP

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

Group Type EXPERIMENTAL

Group PSV

Intervention Type PROCEDURE

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

Group PSV+PEEP

Intervention Type 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.

Interventions

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Group TVB

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.

Intervention Type PROCEDURE

Group PSV

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

Intervention Type PROCEDURE

Group PSV+PEEP

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.

Intervention Type PROCEDURE

Other Intervention Names

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Tidal volume breathing was continued.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Cagin Tanriverdi

Specialist, Department of Anesthesiology and Reanimation, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 41094613 (View on PubMed)

Other Identifiers

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PamukkaleUCTanriverdi-001

Identifier Type: -

Identifier Source: org_study_id