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
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
Anoxia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014