Extubation in Pediatric Patients: Proactive or Passive?

NCT04432701 | Unknown

• 1 other identifier: A/P extubation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cough; Tracheal Extubation

Keywords

passive; proactive; extubation; respiratory complication

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Time to spontaneous eye opening

  Time to spontaneous eye opening

  The time from PACU arrival to spontaneous eye opening, an average of 45 min

• 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 Outcomes (14)

• Time to extubation

  The time from PACU arrival to tracheal extubation, an average of 30 min

• End-tidal concentration of minimum effective alveolar anesthetic concentration

  The time before patients were decided to extubate, within 1 minute

• Age

  6 hours before intervention

• Weight

  6 hours before intervention

• Height

  6 hours before intervention

Study Arms (2)

group A

ACTIVE COMPARATOR

children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.

Behavioral: proactive extubation

group B

NO INTERVENTION

Tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.

Interventions

proactive extubation BEHAVIORAL

when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly

group A

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (6)

• 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.

  PMID: 31273527 BACKGROUND

• 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.

  PMID: 453622 BACKGROUND

• 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.

  PMID: 12707126 BACKGROUND

• 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 abstract available.

  PMID: 7943794 RESULT

• 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.

  PMID: 26202786 RESULT

• 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.

  PMID: 10562778 RESULT

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: June 16, 2020
• Study Start: July 10, 2020
• Primary Completion: December 14, 2020
• Study Completion: April 1, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)