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

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

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

Study Overview

• Status: Completed
• Conditions: Bradycardia; Hypoxemia
• Intervention / Treatment: Other: NPO with 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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei-Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• cannot nasal approach flexible bronchoscopy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Cho-yu Chan, MD
• Investigators: Principal Investigator: Wen-Jue Soong, MD, Department of Pediatrics; Taipei-Veteran General Hospital

Publications and helpful links

General 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. doi: 10.1016/j.ijporl.2011.03.016. Epub 2011 Apr 21.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 12, 2011
• First Submitted That Met QC Criteria: June 24, 2012
• First Posted (Estimate): June 27, 2012

Study Record Updates

• Last Update Posted (Estimate): June 27, 2012
• Last Update Submitted That Met QC Criteria: June 24, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: ventilation; CPR; resuscitation; flexible bronchoscope
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Bradycardia; Hypoxia
• Other Study ID Numbers: VGH-94-269C; NPO-NC-AC in Ped. FB (Other Grant/Funding Number: VGH-94-269C)