The Clinical Value of Applying TOF and TcPO2 to Guide Elderly Patients Extubation

NCT02327910 | Unknown DMC

• 1 other identifier: BeijingMSTC
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Three hundred aged(age\>65y) patients were randomized to Commom group(C group). Qualitative TOF monitoring (TOF group). Qualitative TOF and transcutaneous partial pressure of carbon dioxide monitoring(Unite group). Anesthetic management was standardized in all subjects .The patients of C group were extubated when standard criteria were met; T group patients had a TOF ratio of greater than 0.90 as an additional extubation criterion;and U group patiens were extubated when TOF ratio is greater than 0.90 and meanwhile transcutaneous partial pressure of carbon dioxide recovered to preoperative ±5mmHg .All the patients were transport to the PACU after extubation.Compare the adverse respiratory events at the moment of extubation, on the arrival of PACU, at 30min and 60min moment in the PACU respectively.

Conditions

Postoperative Respiratory Complications

Keywords

Elderly patients，; General anesthesia，; Transcutaneous partial pressure of carbon dioxide(TcPCO2)，; Train-of-four(TOF)，; Extubation; ，Respiratory events

Outcome Measures

Primary Outcomes (1)

• The comparison between groups of postoperative respiratory adverse events

  up to 24 month

Study Arms (3)

Conventional group

NO INTERVENTION

Conventional group:The patients of conventional group were extubated when standard criteria were met;

TOF group

EXPERIMENTAL

TOF group: patients had a TOF ratio of greater than 0.90 as an additional extubation criterion;

Other: TOF group

TOF unit TcPCO2 group

EXPERIMENTAL

Qualitative TOF and transcutaneous partial pressure of carbon dioxide monitoring(Unite group):the patients of U group were extubated when TOF ratio greater than 0.9 and TcPCO2 recovery to preoprative(±5mmHg)

Other: TOF unit TcPCO2 group

Interventions

TOF unit TcPCO2 group OTHER

The patients of U group were extubated when TOF ratio greater than 0.9 and TcPCO2 recovery to preoprative(±5mmHg)

TOF unit TcPCO2 group

TOF group OTHER

The patients of T group were extubated when TOF ratio greater than 0.9.

TOF group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elective general anesthesia surgery elderly patients (age \> 65 years), gastrointestinal surgery

You may not qualify if:

• ASA grade III or IV level, merging, bronchial asthma, chronic obstructive pulmonary disease, severe liver and kidney function is not complete (liver and kidney function corresponding biochemical index 50% above the normal level), neuromuscular disease, and use effect of neuromuscular transmission drugs or severe obesity (BMI \> 35) of the patients

Sponsors & Collaborators

• Beijing Municipal Science & Technology Commission: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The medical team leader

Study Record Dates

• First Submitted: December 20, 2014
• First Posted: December 31, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 23, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share