Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

Bradycardia Clinical Trial

— NPO-NC-AC  

Official title:

Nasopharyngeal Oxygen With Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629186
• Other study ID #: VGH-94-269C
• Secondary ID: NPO-NC-AC in Ped
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: June 24, 2012
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:

• body weight (BW) less than 5.0 kg;

• receiving nasal approach flexible bronchoscopy.

Exclusion Criteria:

• cannot nasal approach flexible bronchoscopy.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bradycardia
• Hypoxemia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei-Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cho-yu Chan, MD

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. doi: 10.1016/j.ijpor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate (beat/min)	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.	Participants will continually monitoring by EKG for 2 days after the procedure.	Yes
Secondary	Oxygen saturation by pulse oximetry	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.	Participants will continually monitoring by pulse oximeter for 2 days after the procedure.	Yes
Secondary	Mean blood pressure (mmHg)	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.	Participants will continually monitoring by sphygmomanometer for 2 days after the procedure.	Yes