BradycardiaNPO-NC-ACNCT01629186
Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy
A study testing NPO with Nose-close and Abdomen-compression in people with Bradycardia and Hypoxemia, run by Cho-yu Chan, MD at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Bradycardia, Hypoxemia
- What is being tested?
- NPO with Nose-close and Abdomen-compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- body weight (BW) less than 5.0 kg;
- receiving nasal approach flexible bronchoscopy.
Who cannot join
- cannot nasal approach flexible bronchoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bradycardia, Hypoxemia
- Being tested
- NPO with Nose-close and Abdomen-compression
- Keywords
- CPR, flexible bronchoscope, resuscitation, ventilation
- Medical subject headings
- Bradycardia, Hypoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPO with Nose-close and Abdomen-compressionOther
Also called (1)Nasopharygeal oxygen, (2)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.
| Study group | Role | What they receive |
|---|---|---|
| outcome | Experimental | 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. Receives: Other: NPO with Nose-close and Abdomen-compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will continually monitoring by EKG for 2 days after the procedure.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Participants will continually monitoring by sphygmomanometer for 2 days after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cho-yu Chan, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Cho-yu Chan, MD, Taipei Veterans General Hospital, Taiwan
- Investigators
- Wen-Jue Soong, MD, Principal investigator, Department of Pediatrics; Taipei-Veteran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629186
- Sponsor's protocol ID
- VGH-94-269C
- Other IDs
- NPO-NC-AC in Ped. FB
- Acronym
- NPO-NC-AC
- Status last verified
- Jun 2012
- First submitted
- 12 Sep 2011
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21513991
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasopharyngeal Oxygen With Nose-close and Abdomen-compression in Pediatric Flexible Bronchoscopy
- ClinicalTrials.gov ID
- NCT01629186
- Acronym / sponsor ID
- NPO-NC-AC / VGH-94-269C
- Conditions
- Bradycardia, Hypoxemia
- Keywords
- CPR, flexible bronchoscope, resuscitation, ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Cho-yu Chan, MDOther government
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outcome | Experimental | Other: NPO with Nose-close and Abdomen-compressionCardiopulmonary 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. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- body weight (BW) less than 5.0 kg;
- receiving nasal approach flexible bronchoscopy.
Key exclusion criteria (1 listed)
- cannot nasal approach flexible bronchoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPO with Nose-close and Abdomen-compressionAlso: (1)Nasopharygeal oxygen, (2)Nose-close and Abdomen-compressionInfants 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 | outcome |
Primary outcome
Heart rate (beat/min)
Time frame: 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.
2 secondary outcomes
Oxygen saturation by pulse oximetry
Time frame: Participants will continually monitoring by pulse oximeter for 2 days after the procedure.
Mean blood pressure (mmHg)
Time frame: Participants will continually monitoring by sphygmomanometer for 2 days after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
- Results publication: PubMed 21513991Soong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Jue Soong, MD principal investigator
Department of Pediatrics; Taipei-Veteran General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPO with Nose-close and Abdomen-compression in people with Bradycardia and Hypoxemia, run by Cho-yu Chan, MD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (beat/min) (time frame: Participants will continually monitoring by EKG for 2 days after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.