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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03370081
Other study ID # CHUBX2017/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date June 1, 2018

Study information

Verified date October 2018
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date June 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CAPNOGRAPHY
MONITORING OF CAPNOMETRY USING ETCO2 METHOD

Locations

Country Name City State
France Centre hospitalier Universitaire de Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary End Tidal CO2 up Percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU) through awakening period in PACU, an average of 30 minutes
Secondary End Tidal CO2 max 1 Maximum EtCO2 reached before the first ventilatory cycle in spontaneaous ventilation through awakening period in PACU, an average of 15 minutes
Secondary End Tidal CO2 max 2 Maximum EtCO2 reached after the first ventilatory cycle in spontaneous ventilation through awakening period in PACU, an average of 30 minutes
Secondary respiratory rate Respiratory rate applied by PACU nurse before the first ventilatory cycle in spontaneous ventilation through awakening period in PACU, an average of 15 minutes
Secondary spontaneous ventilation time Time (in minutes) between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation through awakening period in PACU, an average of 15 minutes
Secondary time for removal of airway device Time (in minutes) between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal through awakening period in PACU, an average of 30 minutes
Secondary Spo2 min Minimal SpO2 after tracheal extubation or laryngeal mask withdrawal through awakening period in PACU, an average of 2 hours
Secondary length of stay in PACU Length of stay in PACU in minutes through awakening period in PACU, an average of 2 hours
Secondary time for oxygenotherapy removal Time (in minutes) between tracheal extubation or laryngeal mask withdrawal and oxygenotherapy weaning through awakening period in PACU, an average of 1 hour
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