Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy

Not Applicable

Completed

• Conditions: Bradycardia; Hypoxemia
• Interventions: Other: NPO with Nose-close and Abdomen-compression

• Registration Number: NCT01629186
• Lead Sponsor: Cho-yu Chan, MD

Brief 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.

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-12
• Study Completion: 2010-12
• Study First Submitted: 2011-09-12
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-24
• Last Update Submitted: 2012-06-24
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

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

Exclusion Criteria

• cannot nasal approach flexible bronchoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
outcome	NPO with Nose-close and Abdomen-compression	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.

Primary Outcome Measures

Name	Time	Method
Heart rate (beat/min)	Participants will continually monitoring by EKG for 2 days after the procedure.	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

Name	Time	Method
Oxygen saturation by pulse oximetry	Participants will continually monitoring by pulse oximeter for 2 days after the procedure.	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)	Participants will continually monitoring by sphygmomanometer for 2 days after the procedure.	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.

Trial Locations

Locations (1)

Taipei-Veterans General Hospital; 🇨🇳 Taipei, Taiwan