Effects of Capnometry Monitoring in Post Anesthesia Care Unit

VENTILATION Clinical Trial

— CAPNOSSPI  

Official title:

Effects of Capnometry Monitoring in Post Anesthesia Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370081
• Other study ID #: CHUBX2017/18
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Capnography
• VENTILATION

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