Extubation in Pediatric Patients: Proactive or Passive?

Cough Clinical Trial

Official title:

Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04432701
• Other study ID #: A/P extubation
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: April 2024

Study information

• Verified date: January 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Smooth extubation process can reduce the complications in recovery time. This study aimed to investigate what is the better time to extubation when children is breathing spontaneously and adequately: waiting until children have movements or wakefulness (passive extubation）or removing endotracheal tube directly (proactive tracheal extubation).

Description:

This is a randomized, controlled cross-over trial. The hypothesis of this study is that the different extubation protocol can impact recovery quality in children in post-anaesthesia care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned off and patients all delivered into PACU for recovery. Patient was positioned on his or her lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the patients regained spontaneous respiration. After spontaneous breathing turn to regular and sufficient（tidal volume >6-8 ml/kg, respiratory rate >10 times per minutes , end tidal carbon dioxide concentration >7.19 mmHg）, the trachea tube could be removed. In Group A, patients were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex. In Group B, tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups. Patients were transported to the ward until they breathed air with a patent airway. The extubation time, recovery characteristics and respiratory complication were recorded.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status aged 3-7 years

Exclusion Criteria:

• a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index>30 kg/m2

Related Conditions & MeSH terms

• Cough
• Tracheal Extubation

Intervention

Behavioral:
• proactive extubation
when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly

Locations

Country	Name	City	State
China	Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (6)

Bidwai AV, Bidwai VA, Rogers CR, Stanley TH. Blood-pressure and pulse-rate responses to endotracheal extubation with and without prior injection of lidocaine. Anesthesiology. 1979 Aug;51(2):171-3. doi: 10.1097/00000542-197908000-00020. No abstract available. — View Citation

Fan Q, Hu C, Ye M, Shen X. Dexmedetomidine for tracheal extubation in deeply anesthetized adult patients after otologic surgery: a comparison with remifentanil. BMC Anesthesiol. 2015 Jul 23;15:106. doi: 10.1186/s12871-015-0088-7. — View Citation

Gonzalez RM, Bjerke RJ, Drobycki T, Stapelfeldt WH, Green JM, Janowitz MJ, Clark M. Prevention of endotracheal tube-induced coughing during emergence from general anesthesia. Anesth Analg. 1994 Oct;79(4):792-5. doi: 10.1213/00000539-199410000-00030. No ab — View Citation

Inomata S, Yaguchi Y, Taguchi M, Toyooka H. End-tidal sevoflurane concentration for tracheal extubation (MACEX) in adults: comparison with isoflurane. Br J Anaesth. 1999 Jun;82(6):852-6. doi: 10.1093/bja/82.6.852. — View Citation

Tsukamoto M, Hitosugi T, Yokoyama T. Comparison of recovery in pediatric patients: a retrospective study. Clin Oral Investig. 2019 Sep;23(9):3653-3656. doi: 10.1007/s00784-019-02993-y. Epub 2019 Jul 4. — View Citation

Valley RD, Freid EB, Bailey AG, Kopp VJ, Georges LS, Fletcher J, Keifer A. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of desflurane and sevoflurane. Anesth Analg. 2003 May;96(5):1320-1324. doi: 10.1213/01.ANE.0000058844.77403.16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coughing	1 if a single cough occurred and saturation by pulse oximetry (SpO2) =95%; 2 if multiple coughs occurred and SpO2 =95%; 3 if multiple coughs occurred and SpO2 <95%; and 4 if multiple coughs occurred, SpO2 <95%, and coughing required administration of i.v . medication.	at the time of extubation within 1 minute
Primary	Respiratory complications	the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2<90%	During the time when patients stayed in PACU after extubation, an average of 45 min
Primary	Time to spontaneous eye opening	Time to spontaneous eye opening	The time from PACU arrival to spontaneous eye opening, an average of 45 min
Primary	Time to discharge from PACU	Time to discharge from PACU	The time from patients arrived PACU to who was decided to discharge from PACU,an average of 1 hour
Secondary	Time to extubation	The time of extubation after surgery	The time from PACU arrival to tracheal extubation, an average of 30 min
Secondary	End-tidal concentration of minimum effective alveolar anesthetic concentration	In percentage	The time before patients were decided to extubate, within 1 minute
Secondary	Age	In years	6 hours before intervention
Secondary	Weight	In kilograms	6 hours before intervention
Secondary	Height	In meters	6 hours before intervention
Secondary	Systolic blood pressure	Hemodynamic parameter	5 minutes before extubation
Secondary	Systolic blood pressure	Hemodynamic parameter	1 minute after extubation
Secondary	Systolic blood pressure	Hemodynamic parameter	5 minutes after extubation
Secondary	Diastolic blood pressure	Hemodynamic parameter	5 minutes before extubation
Secondary	Diastolic blood pressure	Hemodynamic parameter	1 minute after extubation
Secondary	Diastolic blood pressure	Hemodynamic parameter	5 minutes after extubation
Secondary	Heart rate	hemodynamic parameter	5 minutes before extubation
Secondary	Heart rate	hemodynamic parameter	1 minute after extubation
Secondary	Heart rate	hemodynamic parameter	5 minutes after extubation