Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy (NPO-NC-AC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cho-yu Chan, MD, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01629186
First received: September 12, 2011
Last updated: June 24, 2012
Last verified: June 2012
  Purpose

The nasopharyngeal oxygen (NPO) with Nose-close (NC) and Abdomen-compression (AC) technique may use for support or rescue asphyxiated infants during Flexible bronchoscopy.


Condition Intervention
Bradycardia
Hypoxemia
Other: NPO with Nose-close and Abdomen-compression

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nasopharyngeal Oxygen With Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Heart rate (beat/min) [ Time Frame: Participants will continually monitoring by EKG for 2 days after the procedure. ] [ Designated as safety issue: Yes ]
    During and after this FB procedure, vital signs are continually monitoring. When the heart rate (HR) <80 beat/min (measured by continuouse wave and digit form of EKG monitor) and lasting >10 seconds. Immediately rescued with rhythmic NC-AC. If the heart rate did not reach to its acceptable level (>80 beat/min) within 2 minutes, then traditional CPR procedures involving bag-mask ventilation, ET intubation, Ambu bag ventilation or even chest compressions were substituted.


Secondary Outcome Measures:
  • Oxygen saturation by pulse oximetry [ Time Frame: Participants will continually monitoring by pulse oximeter for 2 days after the procedure. ] [ Designated as safety issue: Yes ]
    During FB procedure, vital signs are continually monitoring. When the oxygen saturation <85% (or more than 10% below the original baseline in already cyanotic infant)by pulse oximeter and lasting >10 seconds. Immediately rescued with rhythmic NC-AC. If the oxygen saturation did not reach to its acceptable level (>85%) within 2 minutes, then traditional CPR procedures involving bag-mask ventilation, ET intubation, Ambu bag ventilation or even chest compressions were substituted.

  • Mean blood pressure (mmHg) [ Time Frame: Participants will continually monitoring by sphygmomanometer for 2 days after the procedure. ] [ Designated as safety issue: Yes ]
    During and after the FB procedure, vital signs are continually monitoring. When the mean blood pressure <50mmHg (measured by continuous non-invasive sphygmomanometer every 5 minutes and one hour, respectively) and lasting morethan one hour. Immediately rescued with rhythmic NC-AC. If the mean BP did not reach to its acceptable level (>50mmHg) within 10 minutes, then traditional CPR procedures involving bag-mask ventilation, ET intubation, Ambu bag ventilation or even chest compressions were substituted.


Enrollment: 156
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: outcome

Cardiopulmonary parameters were measured and recorded at baseline, just before and at every minute during NC-AC, and at the end of the FB session. In infants who already had an arterial line, arterial blood gas (ABG) analyses were taken for study. Data was represented as mean ± SD. The results obtained from the baseline and different stages. The values were considered statistically significant only when p < 0.05.

Technique failure was defined as: any vital signs of hypoxia did not return to accepted levels(HR>100 beat/min, SpO2>90%, mean BP>50 mmHg)within 2 minutes of the experimental CPR technique. Then traditional CPR procedures involving bag-mask ventilation, endotracheal intubation, Ambu bag ventilation or even chest compressions were substituted.

Other: NPO with Nose-close and Abdomen-compression
Infants with body weight (BW) <5.0 kg and receiving nasal diagnostic or interventional FB were enrolled. Under NPO (0.5 L/kg/min), when infant's heart rate (HR) <80 beats/min or oxygen saturation (SpO2) <85% for more than 10 seconds, rescue NC-AC was initiated. It was performed by (1) increased NPO flow to 0.5-1.0 L/kg/min; (2) NC 1 second for inspiration; and (3) AC 1 second for expiration with simultaneously released nostrils. Repeat doing steps (2) and (3) at a rate of 30 cycles/min until HR, SpO2, and blood pressure (BP) returned to normal.
Other Names:
  • (1)Nasopharygeal oxygen
  • (2)Nose-close and Abdomen-compression

Detailed Description:

OBJECTIVES: To evaluate the efficacy of a novel cardiopulmonary resuscitation (CPR) technique—nasopharyngeal oxygenation with nose-close and abdomen-compression (NPO-NC-AC)—in small infants during flexible bronchoscopy (FB).

METHODS: Infants with body weight (BW) <5.0 kg and receiving nasal diagnostic or interventional FB (dFB, iFB) were enrolled. Under NPO (0.5 L/kg/min), when infant's heart rate (HR) <80 beats/min or oxygen saturation (SpO2) <85% for more than 10 seconds, rescue NC-AC was initiated. It was performed by (1) increased NPO flow to 0.5-1.0 L/kg/min; (2) NC 1 second for inspiration; and (3) AC 1 second for expiration with simultaneously released nostrils. Repeat doing steps (2) and (3) at a rate of 30 cycles/min until HR, SpO2, and blood pressure (BP) returned to normal. Cardiopulmonary parameters were monitored and analyzed.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • body weight (BW) less than 5.0 kg;
  • receiving nasal approach flexible bronchoscopy.

Exclusion Criteria:

  • cannot nasal approach flexible bronchoscopy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629186

Locations
Taiwan
Taipei-Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Cho-yu Chan, MD
Investigators
Principal Investigator: Wen-Jue Soong, MD Department of Pediatrics; Taipei-Veteran General Hospital
  More Information

Publications:
Responsible Party: Cho-yu Chan, MD, Taipei Veterans General Hospital,Taiwan, Taipei Veterans General Hospital,Taiwan, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01629186     History of Changes
Other Study ID Numbers: VGH-94-269C, NPO-NC-AC in Ped. FB
Study First Received: September 12, 2011
Last Updated: June 24, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
CPR
flexible bronchoscope
resuscitation
ventilation

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014