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EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode (EPO2-PV)

14 september 2017 uppdaterad av: Jean Bussières, Laval University

Evaluation of Different Pre-Oxygenation Conditions in Morbid Obesity: Position and Ventilation Mode, in a Respiratory Physiology Laboratory, on Voluntary Subjects

The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature.

This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

Complications related to airway management are the major contributing factor to morbidity in anesthesiology. This risk of complications markedly increases when faced with a difficult airway in an obese patient. Pre-oxygenation creates a safety margin by increasing the patient's oxygen stores, through a higher functional residual capacity (FRC). When pre-oxygenated, the clinician may proceed to intubation after a variable period of apnea, while maintaining oxygen saturation over 92%. In non-obese individuals, pre-oxygenation allows a non-hypoxic apnea time of eight minutes. In the obese population, however, this non-hypoxic apnea time decreases to two to three minutes.

Different methods of pre-oxygenation have been proposed in order to increase apnea time before significant oxygen desaturation. Amongst these methods, the following are of particular interest: pre-oxygenation to vital capacity, pre-oxygenation with spontaneous ventilation and positive pressure, and pre-oxygenation with elevated head positioning ("beach-chair"). These methods have been extensively studied in individuals of normal height and weight.

The main objective of pre-oxygenation is to raise oxygen levels available at the alveolar level in order to increase the non-hypoxic apnea time, before a significant desaturation occurs. This raised alveolar oxygen concentration can be done by maintaining a higher inspired oxygen fraction and by promoting a larger FRC which is the oxygen reserve build through the pre-oxygenation phase. In morbid obese patients, these parameters are affected by a lower expiratory flow, lower expiratory flow and closing of small radius airways. The final result probably come from a more cephalad position of the diaphragm induced by a larger intra-abdominal volume.

Actually, different studies demonstrate the advantage of a beach-chair position and non-invasive positive pressure ventilation for pre-oxygenation of obese patients. These advantages are shown by a shorter time of pre-oxygenation to obtain an end-tidal O2 > 90 % and a longer non-hypoxic apnea time (Sat O2 >90%). Up to date, there is no published data on the FRC as a result of different combinations of position and ventilation mode. This study will evaluate FRC by helium dilution technique.

We propose a crossover randomised trial on volunteers waiting for a bariatric surgery. We want to compare, in pre-oxygenation situation, without induction of general anesthesia, the effect of three positions and two ventilation modes on the FRC measure.

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

    • Quebec
      • Quebec city, Quebec, Kanada, G1V4G5
        • Institut Universitaire de cardiologie et de pneumologie de Quebec

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • BMI 40 - 80 kg / m2
  • Waist circumference: Men: More than 130 cm
  • Waist circumference: Women: More than 115 cm

Exclusion Criteria:

  • Facial hair
  • Cranio-facial abnormality
  • Claustrophobia
  • Asthma
  • COPD (defined by FEV1 < 80 %)
  • Severe cardiovascular disease (defined by NYHA ≥3)
  • Pregnancy
  • Tobacco use
  • NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Supine
NIPPV and Tidal volume

Ventilation: non-invasive positive pressure ventilation (NIPPV)

Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)

Tidal volume spontaneous ventilation, no assistance.
Experimentell: Beach-chair (Back : 25 deg)
NIPPV and Tidal volume

Ventilation: non-invasive positive pressure ventilation (NIPPV)

Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)

Tidal volume spontaneous ventilation, no assistance.
Experimentell: Proclive (Global 25 deg)
NIPPV and Tidal volume

Ventilation: non-invasive positive pressure ventilation (NIPPV)

Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)

Tidal volume spontaneous ventilation, no assistance.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Residual Capacity
Tidsram: After a 5 minutes pre-oxygenation period
Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.
After a 5 minutes pre-oxygenation period

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diaphragmatic Amplitude.
Tidsram: After a 5 minutes pre-oxygenation period
Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
After a 5 minutes pre-oxygenation period
Respiratory Mechanics
Tidsram: At the end of a 5 minutes pre-oxygenation period
Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described.
At the end of a 5 minutes pre-oxygenation period
Patient's Comfort
Tidsram: At the end of a 5 minutes pre-oxygenation period
Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
At the end of a 5 minutes pre-oxygenation period

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Vital Signs
Tidsram: At the end of a 5 minutes pre-oxygenation period
Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
At the end of a 5 minutes pre-oxygenation period

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Etienne J Couture, MD, Laval University

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2014

Primärt slutförande (Faktisk)

1 juni 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

22 april 2014

Först inskickad som uppfyllde QC-kriterierna

23 april 2014

Första postat (Uppskatta)

24 april 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 april 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2017

Senast verifierad

1 september 2017

Mer information

Termer relaterade till denna studie

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