Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy - Full Text View

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:

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

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

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:

Soong WJ, Shiao AS, Jeng MJ, Lee YS, Tsao PC, Yang CF, Soong YH. Comparison between rigid and flexible laser supraglottoplasty in the treatment of severe laryngomalacia in infants. Int J Pediatr Otorhinolaryngol. 2011 Jun;75(6):824-9. Epub 2011 Apr 21.

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 May 23, 2013

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