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N/A N=91 Randomized Single-blind Treatment

Preoxygenation Using THRIVE Versus Facemask in Parturients

Preoxygenation

Enrolled (actual)
91
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Preoxygenation Duration — 3.6; NA; NA minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Facemask preoxygenation (Device); THRIVE preoxygenation (Device)
Age
Adult, Older Adult · 19+ yrs
Sex
Female
Sponsor
University of British Columbia
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Preoxygenation Duration
3.6; NA; NA
SECONDARY
Proportion to Reach End Tidal Oxygen (ETO2) of 90 Percent at 3 Minutes
10; 0; 0
SECONDARY
Proportion to Reach EtO2 of 90 Percent at 4 Minutes
26; 2; 4
SECONDARY
Proportion to Reach EtO2 of 90 Percent at 5 Minutes
0; 0; 0
SECONDARY
Proportion to Reach EtO2 of 90 Percent at 6 Minutes
0; 0
SECONDARY
Proportion to Reach EtO2 of 90 Percent at 7 Minutes
0; 0; 0
SECONDARY
Proportion to Reach EtO2 of 90 Percent at 8 Minutes
0; 1; 5
SECONDARY
Comfort Score
4; 4; 4
SECONDARY
Acceptability Score
5; 4.5; 5

Summary

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

Eligibility Criteria

Inclusion Criteria

  • Pregnant patients ≥36 weeks gestation.
  • Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor.
  • American Society of Anesthesiologists (ASA) class 2.

Exclusion Criteria

  • Any medical conditions that are likely to affect gas exchange.
  • Obstructed nasal passage.
  • Unable to tolerate a tight fitting facemask.
  • Body Mass Index ≥40 kg/m2.
  • Patients who are in active labor (i.e. cervical dilation ≥4cm).
  • Patients who are unable to give informed consent.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03772574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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