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Prospective multi-center controlled trial: modified apnea testing

Prospective multi-center controlled trial: modified apnea testing

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDB-17013196
Enrollment
Unknown
Registered
2017-10-31
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain death

Interventions

Gold Standard:Standard AP procedure

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. aged =18 years old; 2. deep coma, absence of brainstem reflexes, and fulfill at least two of the three confirmatory tests (SLSEP, EEG and TCD); 3. fulfill the AP prerequisites: bladder or rectal temperature =36.5 degree C, systolic blood pressure maintained =90mmHg or mean arterial pressure =60mmH, preoxygenation with 100% oxygen for 10-15min to an arterial partial pressure of oxygen (PaO2) =200mmHg; 4. invasive arterial blood pressure monitoring and bedside arterial blood gas (ABG) analysis; 5. consent from the patient surrogates.;Inclusion criteria: 1. aged =18 years old; 2. deep coma, absence of brainstem reflexes, and fulfill at least two of the three confirmatory tests (SLSEP, EEG and TCD); 3. fulfill the AP prerequisites: bladder or rectal temperature =36.5 degree C, systolic blood pressure maintained =90mmHg or mean arterial pressure =60mmH, preoxygenation with 100% oxygen for 10-15min to an arterial partial pressure of oxygen (PaO2) =200mmHg; 4. invasive arterial blood pressure monitoring and bedside arterial blood gas (ABG) analysis; 5. consent from the patient surrogates.;Inclusion criteria: 1. aged =18 years old; 2. deep coma, absence of brainstem reflexes, and fulfill at least two of the three confirmatory tests (SLSEP, EEG and TCD); 3. fulfill the AP prerequisites: bladder or rectal temperature =36.5 degree C, systolic blood pressure maintained =90mmHg or mean arterial pressure =60mmH, preoxygenation with 100% oxygen for 10-15min to an arterial partial pressure of oxygen (PaO2) =200mmHg; 4. invasive arterial blood pressure monitoring and bedside arterial blood gas (ABG) analysis; 5. consent from the patient surrogates.;Inclusion criteria: 1. aged =18 years old; 2. deep coma, absence of brainstem reflexes, and fulfill at least two of the three confirmatory tests (SLSEP, EEG and TCD); 3. fulfill the AP prerequisites: bladder or rectal temperature =36.5 degree C, systolic blood pressure maintained =90mmHg or mean arterial pressure =60mmH, preoxygenation with 100% oxygen for 10-15min to an arterial partial pressure of oxygen (PaO2) =200mmHg; 4. invasive arterial blood pressure monitoring and bedside arterial blood gas (ABG) analysis; 5. consent from the patient surrogates.;Inclusion criteria: 1. aged =18 years old; 2. deep coma, absence of brainstem reflexes, and fulfill at least two of the three confirmatory tests (SLSEP, EEG and TCD); 3. fulfill the AP prerequisites: bladder or rectal temperature =36.5 degree C, systolic blood pressure maintained =90mmHg or mean arterial pressure =60mmH, preoxygenation with 100% oxygen for 10-15min to an arterial partial pressure of oxygen (PaO2) =200mmHg; 4. invasive arterial blood pressure monitoring and bedside arterial blood gas (ABG) analysis; 5. consent from the patient surrogates.

Exclusion criteria

Exclusion criteria: 1. arterial partial pressure of carbon dioxide unable to decrease to 45mmHg or below; 2. receive extracorporeal membrane oxygenation (ECMO) treatment; 3. physician or surrogates refuse the AP.;Exclusion criteria: 1. arterial partial pressure of carbon dioxide unable to decrease to 45mmHg or below; 2. receive extracorporeal membrane oxygenation (ECMO) treatment; 3. physician or surrogates refuse the AP.;Exclusion criteria: 1. arterial partial pressure of carbon dioxide unable to decrease to 45mmHg or below; 2. receive extracorporeal membrane oxygenation (ECMO) treatment; 3. physician or surrogates refuse the AP.;Exclusion criteria: 1. arterial partial pressure of carbon dioxide unable to decrease to 45mmHg or below; 2. receive extracorporeal membrane oxygenation (ECMO) treatment; 3. physician or surrogates refuse the AP.;Exclusion criteria: 1. arterial partial pressure of carbon dioxide unable to decrease to 45mmHg or below; 2. receive extracorporeal membrane oxygenation (ECMO) treatment; 3. physician or surrogates refuse the AP.

Design outcomes

Primary

MeasureTime frame
AP successful rate;Arterial blood gas analysis;

Secondary

MeasureTime frame
Duration of AP test;

Countries

China

Contacts

Public ContactYingying Su;Yingying Su;Yingying Su;Yingying Su;Yingying Su ;;;;

Xuanwu Hospital Capital Medical University;Xuanwu Hospital Capital Medical University;Xuanwu Hospital Capital Medical University;Xuanwu Hospital Capital Medical University;Xuanwu Hospital Capital Medical University

tangsuyingying@sina.com;tangsuyingying@sina.com;tangsuyingying@sina.com;tangsuyingying@sina.com;tangsuyingying@sina.com+86 15901361953;+86 15901361953;+86 15901361953;+86 15901361953;+86 15901361953

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026