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Trial record 29 of 579 for:    CARBON DIOXIDE AND anesthesia

Effects of Capnometry Monitoring in Post Anesthesia Care Unit (CAPNOSSPI)

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ClinicalTrials.gov Identifier: NCT03370081
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Karine Nouette-Gaulain, University Hospital, Bordeaux

Brief Summary:
There is few information about the best capnometry value in recovery room for intubated awakening patients. Furthermore, capnometry values could influence ventilation applied by nurses on these patients. The aim of this study is to observe the effects of capnometry monitoring on intubated awakening patients in recovery room.

Condition or disease Intervention/treatment Phase
VENTILATION Capnography Device: CAPNOGRAPHY Not Applicable

Detailed Description:

In France, there is actually no recommandation about capnography monitoring in recovery rooms. Nevertheless, some patients are still ventilated in post-anesthesia care units during awakening period. Alveolar hypoventilation could induce moderate hypercapnia, thereby stimulate central ventilatory command. However, this hypoventilation could delay the clearance of anesthetic gases. Capnometry monitoring could influence ventilation applied to these patients. Recovery rooms nurses would perform moderate hyperventilation in response to hign capnometry values. This method could enhance gases elimination, with faster spontaneous breathing recovery and extubation. Length of stay in recovery room could also be shortened. An objective surrogate of ventilation is maximal End Tidal CO2, if there is no alveolo-capillary gradient abnormality (Obesity, Chronic respiratory disease, Cyanogenic heart disease). Thus, this study will compare the percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU) in 2 groups :

  • first group ("non-blind group") with capnography monitoring see by the PACU nurses
  • second group ("blind group") with capnography monitoring but PACU nurses cannot see the values Other parameters like the time between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation, the time between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal, the minimal SpO2 reached after tracheal extubation or laryngeal mask withdrawal or the length of stay in PACU are also recorded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Effects of Capnometry Monitoring in Post Anesthesia Care Unit
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : June 1, 2018

Arm Intervention/treatment
Experimental: CAPNO+
END TIDAL CO2(EtCO2) is monitoring and PACU nurses can see the values delivered by the capnography device
Device: CAPNOGRAPHY
MONITORING OF CAPNOMETRY USING ETCO2 METHOD

No Intervention: CAPNO-
END TIDAL CO2(EtCO2) is monitoring but PACU nurses cannot see the values delivered by the capnography device



Primary Outcome Measures :
  1. End Tidal CO2 up [ Time Frame: through awakening period in PACU, an average of 30 minutes ]
    Percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU)


Secondary Outcome Measures :
  1. End Tidal CO2 max 1 [ Time Frame: through awakening period in PACU, an average of 15 minutes ]
    Maximum EtCO2 reached before the first ventilatory cycle in spontaneaous ventilation

  2. End Tidal CO2 max 2 [ Time Frame: through awakening period in PACU, an average of 30 minutes ]
    Maximum EtCO2 reached after the first ventilatory cycle in spontaneous ventilation

  3. respiratory rate [ Time Frame: through awakening period in PACU, an average of 15 minutes ]
    Respiratory rate applied by PACU nurse before the first ventilatory cycle in spontaneous ventilation

  4. spontaneous ventilation time [ Time Frame: through awakening period in PACU, an average of 15 minutes ]
    Time (in minutes) between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation

  5. time for removal of airway device [ Time Frame: through awakening period in PACU, an average of 30 minutes ]
    Time (in minutes) between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal

  6. Spo2 min [ Time Frame: through awakening period in PACU, an average of 2 hours ]
    Minimal SpO2 after tracheal extubation or laryngeal mask withdrawal

  7. length of stay in PACU [ Time Frame: through awakening period in PACU, an average of 2 hours ]
    Length of stay in PACU in minutes

  8. time for oxygenotherapy removal [ Time Frame: through awakening period in PACU, an average of 1 hour ]
    Time (in minutes) between tracheal extubation or laryngeal mask withdrawal and oxygenotherapy weaning



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patients with given written consent
  • General anesthesia, induction with Propofol infusion and Target-Controlled Infusion (TCI) remifentanil, relayed with inhaled sevoflurane and TCI remifentanil
  • Upper airway control with naso-orotracheal tube or laryngeal mask
  • Ventilated normotherm patients in PACU

Exclusion Criteria:

  • Minor or pregnant patients
  • Obesity with Body Mass Index > 40 kg/m²
  • Chronic respiratory disease with SpO2<90% in ambiant air
  • Cyanogenic heart disease
  • Patients under myorelaxant in PACU

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370081


Locations
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France
Centre hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: Karine Nouette-Gaulain, M.D; PH.D. Head of department, Anesthesiology and ICU, clinical professor, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03370081     History of Changes
Other Study ID Numbers: CHUBX2017/18
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karine Nouette-Gaulain, University Hospital, Bordeaux:
Capnometry
Capnography
ETCO2
Recovery room
Post-anesthesia care unit
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs